Chrysalis Intelligence · Sponsors · Instrumentation Laboratory CO

Instrumentation Laboratory CO

Bedford, MA, US · 13 510(k) clearances · 38 recalls

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Total clearances
13
2020-08-19 → 2023-12-29
Last 12 months
0
Product codes
8
Most recent
2023-12-29
Name variants in FDA filings: Instrumentation Laboratory / Instrumentation Laboratory Company / Instrumentation Laboratory CO
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
GGP Test, Qualitative And Quantitative Factor Deficiency Class II Hematology 3 2023-12-13
JPA — — — 2 2023-12-29
CHL — — — 2 2023-08-10
QLU — — — 2 2023-06-23
GKP — — — 1 2023-06-21
CGA — — — 1 2023-01-27
KFF Assay, Heparin Class II Hematology 1 2022-10-04
GJS Test, Time, Prothrombin Class II Hematology 1 2022-08-16
Safety

Recalls (38)

Class I (serious)
0
Risk of injury / death
Total recalls
38
Currently ongoing
38
Most recent
2026-01-20
DateSeverityStatusRecall # ProductCodeReason
2026-01-20 Class II Ongoing Z-1543-2026 GEM Premier 5000; Part No. 00055445010 & 00055445011. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution …
2026-01-20 Class II Ongoing Z-1542-2026 GEM Premier 5000; Part No. 00055445008. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution …
2026-01-20 Class II Ongoing Z-1541-2026 GEM Premier 5000; Part No. 00055445004. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution …
2026-01-20 Class II Ongoing Z-1540-2026 GEM Premier 5000; Part No. 00055430011. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution …
2026-01-20 Class II Ongoing Z-1539-2026 GEM Premier 5000; Model No. 00055430010. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution …
2026-01-20 Class II Ongoing Z-1538-2026 GEM Premier 5000; Part No. 00055430008. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution …
2026-01-20 Class II Ongoing Z-1537-2026 GEM Premier 5000; Part No. 00055430004. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution …
2026-01-20 Class II Ongoing Z-1536-2026 GEM Premier 5000; Part No: 00055415011. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution …
2026-01-20 Class II Ongoing Z-1535-2026 GEM Premier 5000; Part No. 00055415010. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution …
2026-01-20 Class II Ongoing Z-1534-2026 GEM Premier 5000; Part No. 00055415008. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution …
2026-01-20 Class II Ongoing Z-1533-2026 GEM Premier 5000; Part No. 00055415005. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution …
2026-01-20 Class II Ongoing Z-1532-2026 GEM Premier 5000 PAK; Part No. 00055415004. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution …
2026-01-20 Class II Ongoing Z-1531-2026 GEM Premier 5000 PAK; Part No. 00055407511. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution …
2026-01-20 Class II Ongoing Z-1530-2026 GEM Premier 5000 PAK; Part No. 00055407510. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution …
2026-01-20 Class II Ongoing Z-1529-2026 GEM Premier 5000 PAK; Part No. 00055407508. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution …
2026-01-20 Class II Ongoing Z-1528-2026 GEM Premier 5000 PAK; Part No. 00055407504. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution …
2026-01-20 Class II Ongoing Z-1527-2026 GEM Premier 5000 PAK; Part No. 00055360011. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution …
2026-01-20 Class II Ongoing Z-1526-2026 GEM Premier 5000 PAK; Part No. 00055360010. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution …
2026-01-20 Class II Ongoing Z-1525-2026 GEM Premier 5000 PAK; Part No. 00055360008. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution …
2026-01-20 Class II Ongoing Z-1524-2026 GEM Premier 5000 PAK, Part No. 00055360004. — Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution …
2025-12-11 Class II Ongoing Z-1095-2026 The product is used for the evaluation of the intrinsic coagulation pathway, APTT substitution test and the monitoring o… — Potential for microbial contamination.
2025-11-18 Class III Ongoing Z-0938-2026 HemosIL SynthAFax. Partial Thromboplastin Time Tests. — Recalled lots were manufactured with double the amount of preservative concentration.
2025-02-03 Class II Ongoing Z-2323-2025 HemosIL LMW Heparin Controls; Part Number: 0020300200; — Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert ac…
2024-12-18 Class II Ongoing Z-1020-2025 HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic — Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance ran…
2023-09-29 Class II Ongoing Z-0359-2024 GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate, Part Numbers 00024315009, 00024330009, 00… — Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 le…
2023-09-29 Class II Ongoing Z-0358-2024 GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 0002434500… — Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 le…
2023-09-29 Class II Ongoing Z-0357-2024 GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330004, 00024345004 — Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 le…
2023-07-13 Class II Ongoing Z-2578-2023 ACL TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemostasis laboratory for coagulati… — Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
2023-02-03 Class II Ongoing Z-1307-2023 ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation… — Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
2023-02-03 Class II Ongoing Z-1306-2023 ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/… — Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
2023-02-03 Class II Ongoing Z-1305-2023 ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibri… — Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
2023-02-03 Class II Ongoing Z-1304-2023 ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinol… — Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
2022-04-08 Class II Ongoing Z-1052-2022 HemosIL ReadiPlasTin, Part No. 0020301400 — Variable and out of specification QC results with HemosIL ReadiPlasTin. IL will remove all lots from the market and convert customers to an alternative prothro…
2022-02-22 Class II Ongoing Z-1014-2022 ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS … — Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or r…
2021-10-13 Class II Ongoing Z-0276-2022 HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent. — The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonge…
2021-08-25 Class II Ongoing Z-0151-2022 HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) a… — Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
2021-08-25 Class II Ongoing Z-0150-2022 HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical… — Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
2021-08-25 Class II Ongoing Z-0149-2022 HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) a… — Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
Filings

All 510(k) clearances (13)

Date K-number Device Code Class Specialty
2023-12-29 K233790 ACL TOP 970 CL JPA — —
2023-12-13 K230852 HemosIL Chromogenic Factor IX GGP Class II Hematology
2023-09-29 K221359 ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM JPA — —
2023-08-10 K223608 GEM Premier 7000 with IQM3 CHL — —
2023-06-23 K223187 HemosIL Liquid Anti-Xa QLU — —
2023-06-21 K231031 ACL TOP Family 70 Series GKP — —
2023-01-27 K223090 GEM Premier ChemSTAT CGA — —
2022-12-09 K223402 HemosIL von Willebrand Factor Antigen GGP Class II Hematology
2022-10-04 K213464 HemosIL Liquid Anti-Xa KFF Class II Hematology
2022-08-16 K213426 HemosIL ReadiPlasTin GJS Class II Hematology
2021-08-20 K203790 GEM Premier 5000 CHL — —
2020-09-17 DEN190032 HemosIL Liquid Anti-Xa QLU — —
2020-08-19 K200033 HemosIL von Willebrand Factor Antigen GGP Class II Hematology
Data source: openFDA · Generated 2026-08-27 08:58 · Last ingest 2026-08-27T12:58:10.687222 · Pipeline: Chrysalis Intelligence