| 2026-04-22 |
Class II
|
Ongoing |
Z-2067-2026 |
BioFire Joint Infection (JI) Panel REF: RFIT-ASY-0138, 30 test Kit. |
— |
Contamination to in-vitro diagnostic test may result in false positives. |
| 2026-04-01 |
Class II
|
Ongoing |
Z-2081-2026 |
Biofire Spotfire Respiratory/Sore Throat Panel REF: 423485 |
— |
Respiratory/sore throat panel test may result in false negative results and control failures. |
| 2025-10-22 |
Class II
|
Ongoing |
Z-0602-2026 |
BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) |
— |
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures. |
| 2025-04-30 |
Class II
|
Ongoing |
Z-1877-2025 |
BioFire Respiratory Panel 2.1 plus Kit, REF: 423740, For Filmarray systems |
— |
Due to manufacturing error, respiratory panel may result in elevated control failures and/or false negative results. |
| 2025-02-27 |
Class II
|
Ongoing |
Z-1518-2025 |
FilmArra Pneumonia Panel plus (Pneumoplus), REF: RFIT-LBL-0374 |
— |
Increased risk of control failures and false negative test results with multiplexed nucleic acid test. |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3123-2024 |
FILMARRAY TORCH MODULE BOX, HTFA-ASY-0003, HTFA-ASY-0003-W, HTFA-ASY-0003U |
— |
Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that m… |
| 2024-08-07 |
Class II
|
Ongoing |
Z-3122-2024 |
FILMARRAY 2.0 INSTRUMENT, REF: FLM2-ASY-0001, FLM2-ASY-0001-W |
— |
Some automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal equipment that m… |
| 2024-06-19 |
Class II
|
Ongoing |
Z-2456-2024 |
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunctio… |
— |
If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may oc… |
| 2024-06-10 |
Class II
|
Ongoing |
Z-2683-2024 |
BIOFIRE FILMARRAY Pneumonia Panel plus, REF: RFIT-ASY-0143 |
— |
Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer. |
| 2024-06-10 |
Class II
|
Ongoing |
Z-2682-2024 |
BIOFIRE FILMARRAY Pneumonia Panel, REF: RFIT-ASY-0144 |
— |
Pneumonia panels have an increased risk of control failures due to an issue in the manufacturing process, which could lead to delayed results for the customer. |
| 2024-05-16 |
Class II
|
Ongoing |
Z-2514-2024 |
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY Gastrointestinal (GI… |
— |
Due to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium. |
| 2024-01-26 |
Class II
|
Ongoing |
Z-1140-2024 |
FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal micro… |
— |
Due to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel. |
| 2024-01-26 |
Class II
|
Ongoing |
Z-1139-2024 |
BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Ped… |
— |
Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums |
| 2023-12-14 |
Class II
|
Ongoing |
Z-0994-2024 |
FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit) |
— |
Their is a potential for false positive results when using Pneumonia panel. |
| 2023-12-14 |
Class II
|
Ongoing |
Z-0993-2024 |
FilmArray Pneumonia Panel Plus (Pneumoplus), REF: RFIT-ASY-0143, CED 2797, IVD, Rx Only (30 test kit) |
— |
Their is a potential for false positive results when using Pneumonia panel. |
| 2023-11-27 |
Class II
|
Ongoing |
Z-0704-2024 |
The BIOFIRE Respiratory Panel 2.1 (RP2.1) is a PCR-based multiplexed nucleic acid test intended for use with the BIOFIRE… |
— |
A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to i… |
| 2023-11-27 |
Class II
|
Ongoing |
Z-0703-2024 |
BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test i… |
— |
A manufacturing event may contribute to elevated rates of false negative results while using gastrointestinal panel and respiratory panel, which could lead to i… |
| 2023-10-17 |
Class II
|
Ongoing |
Z-0451-2024 |
BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, used with Maine Molecular Quality Controls, In… |
— |
Routine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control panel/instrume… |
| 2023-10-17 |
Class II
|
Ongoing |
Z-0353-2024 |
FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen… |
— |
Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the swi… |
| 2023-05-08 |
Class II
|
Ongoing |
Z-2440-2023 |
FilmArray Pneumonia Panel (Pneumo), REF: RFIT-ASY-0145, For FILMARRAY systems, CE 2797, IVD, Rx Only |
— |
Due to manufacturing issue, panels may result in false negative results. |
| 2023-05-08 |
Class II
|
Ongoing |
Z-2439-2023 |
BioFire Respiratory Panel 2.1 (RP2.1), REF: 423742, For FILMARRAY systems, IVD, Rx Only |
— |
Due to manufacturing issue, panels may result in false negative results. |
| 2023-04-25 |
Class II
|
Ongoing |
Z-2588-2023 |
FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module Software |
— |
The firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE¿ FILMARRAY¿ Gastrointestinal (GI)… |
| 2023-03-08 |
Class II
|
Ongoing |
Z-1392-2023 |
FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems, REF: RFIT-ASY-0116, (30 pouches/kit) |
— |
Due to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results. |
| 2023-02-01 |
Class II
|
Ongoing |
Z-1253-2023 |
In Vitro Diagnostic (IVD) Panel FilmArray GI Panel - REF RFIT-ASY-0116 |
— |
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance… |
| 2023-02-01 |
Class II
|
Ongoing |
Z-1252-2023 |
In Vitro Diagnostic (IVD) Panel BioFire Respiratory Panel 2.1 (RP2.1) - REF 423742 |
— |
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance… |
| 2023-02-01 |
Class II
|
Ongoing |
Z-1251-2023 |
In Vitro Diagnostic (IVD) Panel BioFire BCID2 Panel - REF RFIT-ASY-0147 |
— |
Due to temperature excursions with products (products being stored outside of the required temperature specifications) that may cause a reduction in performance… |
| 2021-10-11 |
Class II
|
Terminated |
Z-0312-2022 |
BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog N… |
— |
Due to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable contamination in the… |
| 2021-07-20 |
Class II
|
Terminated |
Z-2245-2021 |
FilmArray Blood Culture Identification (BCID) Panel Product Pouch Label: FilmArray BCID Panel Part No: RFIT-ASY-0… |
— |
Due to product complaints received for false negative results (dropouts) with blood culture identification panel potential caused by a pouch manufacturing error… |
| 2021-06-07 |
Class II
|
Terminated |
Z-2040-2021 |
FilmArray Pneumonia Panel plus (Pneumoplus) Part Numbers: Part No: RFIT-ASY-0143 / UDI: 00815381020314 (30 test kit)… |
— |
Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame. |
| 2021-06-07 |
Class II
|
Terminated |
Z-2039-2021 |
FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No: RFIT-ASY-0144 / UDI: 00815381020178 (30 test kit) Part No… |
— |
Due to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame. |
| 2021-05-10 |
Class II
|
Terminated |
Z-1903-2021 |
BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnosti… |
— |
Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmAr… |
| 2021-04-16 |
Class II
|
Terminated |
Z-1944-2021 |
FilmArray Pneumonia Panel (Penumo) REF RFIT-ASY-0144 |
— |
Elevated rates of false positive/false negative and control failures while using the Pneumonia Panel, due to issues identified in the manufacturing process. |
| 2021-01-26 |
Class II
|
Terminated |
Z-1158-2021 |
BioFire BCID2 Panel; IVD, Rx Only Part No: RFIT-ASY-0147 / UDI: 00815381020338 - Product Usage: intended for use with Fi… |
— |
The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials… |
| 2021-01-26 |
Class II
|
Terminated |
Z-1157-2021 |
Gram-Negative Bacteria And Associated Resistance Markers; Film Array Blood Culture Identification (BCID); Film Array BC… |
— |
The firm has identified an increased risk of false positive Pseudomonas aeruginosa when BCID/BCID2 Panels are used with specific BD BACTEC" blood culture vials… |
| 2020-01-22 |
Class II
|
Terminated |
Z-2296-2020 |
FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood… |
— |
There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blo… |
| 2020-01-22 |
Class II
|
Terminated |
Z-2295-2020 |
FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Bloo… |
— |
There is an increased risk of false positive Proteus results when using the Film Array Blood Culture Identification Panel (BCID) in vitro diagnostic test of blo… |