| 2023-05-24 |
Class II
|
Ongoing |
Z-2210-2023 |
RET Distal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating a… |
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DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. |
| 2023-05-24 |
Class II
|
Ongoing |
Z-2209-2023 |
RET Proximal Probe. Used in Fluorescence in situ hybridization (FISH), a laboratory technique for detecting and locating… |
— |
DNAs used during the manufacture of two affected models were accidentally inverted during manufacturing. |
| 2022-10-27 |
Class II
|
Terminated |
Z-0353-2023 |
CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy. This device is an analyte sp… |
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Device is mislabeled. The package insert for this ASR device contains a chromomap - an image showing the position the FISH probe maps to on the specific chromos… |
| 2022-10-27 |
Class II
|
Terminated |
Z-0341-2023 |
CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent Ref: MPD39782 |
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An error with the chromomap on version 1 of the package insert which is incorrect. The nucleotide locations specified in the insert are correct but the map has … |
| 2022-02-14 |
Class III
|
Terminated |
Z-0824-2022 |
Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008 |
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Labelled with an incorrect expiry date on the outer label with an extended expiry date than the validated shelf life. The correct expiry date for the device is… |
| 2022-02-04 |
Class III
|
Terminated |
Z-0814-2022 |
TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequenc… |
— |
May show unexpected locus specific signals in addition to those at 14q32. |
| 2022-01-18 |
Class II
|
Terminated |
Z-0741-2022 |
Del(5q) Deletion FISH Probe Kit: In-Vitro Diagnostic to detect deletions in chromosome location from patients with AML o… |
— |
individual components have been labelled with incorrect colours. The red and green colours are opposite to those specified in the product labelling. The EGR1 pr… |
| 2021-05-27 |
Class II
|
Terminated |
Z-2323-2021 |
Cytocell LPH019-A E2A (TCF3) Breakapart Probe- In Vitro Diagnostic Analyte specific reagents (ASR's) |
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May show unexpected locus specific signals in addition to those at 19p13.3. Users may observe faint additional locus specific signals at 9q34 |
| 2021-05-17 |
Class II
|
Terminated |
Z-2134-2021 |
CytoCell DiGeorge/VCFS TUPLE1 Region and 22q13.3 Region Probe, Model Number LPU004-A. analyte specific reagent for in v… |
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The device may show unexpected locus specific signals in addition to those at 22q. Users may observe faint additional locus specific signals at 20p12/13. |
| 2021-03-19 |
Class II
|
Ongoing |
Z-1493-2021 |
Chromosome X Alpha-Satellite in FITC Spectrum - Product Usage: Analyte Specific Reagents. Model: MPA3481 |
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Users may observe additional locus specific signals at 9q34. The device pack insert indicates the probe has no known cross-reactivity to 9q34. |
| 2020-12-22 |
Class II
|
Terminated |
Z-1099-2021 |
Aquarius LPH 511-A CRLF2 Distal Probe Green, model no. LPH 511-A The CRLF2 Distal probe, labelled in green, consists … |
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Users may observe very faint additional locus specific signals at 11q13. There is a low risk of a normal sample being reported as not normal in a resulting labo… |
| 2020-07-17 |
Class II
|
Terminated |
Z-2829-2020 |
Cytocell LPH533-A NUP98 Distal Probe Green - Product Usage:The NUP98 Distal probe, labelled in green, consists of a 151k… |
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A low risk of a false positive result being issued with a laboratory developed test (LDT) that utilizes the LPH533-A NUP98 Distal Probe Green. |