Device product
GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092 2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI: (01)07090038460108 3. Gentian C E, BCI Ref: A52763, Cystatin C calibrator Kit, 6 x 1 mL, REF 1051, (01)17090038460037 4. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 8012 (Not distributed in US)
Z-0099-2021
Product summary
- Firm
- Gentian AS
- Event
- Event 86465
- Status
- Terminated
- Classification
- Class II
- Quantity
- 107 calibrator kits
- Official record key
device-enforcement:Z-0099-2021
Official wording
Reason: The firm has identified lots of calibrators that have shown to measure incorrect high values over time compared to the assigned values when released for distribution. This could result in higher Cystatin C values measured in patients.
Code information: Lot numbers #s: 1905415,1904404,1904403,1809403
Distribution pattern: US: MN, VA, KS,
Derived failure modes
-
Unknown
The firm has identified lots of calibrators that have shown to measure incorrect high values over time compared to the assigned values when released for distribution. This could result in higher Cystatin C values measured in patients.