Reported Oct 21, 2020 · Terminated
GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models
Gentian AS
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Gentian AS · Bjornasveien 5 · Moss, N/A · N/A
Is this the product you have?
GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models
4 of 4 products
| Model / number | Barcodes | Product as published |
|---|---|---|
1012 | 07090038460092 | Gentian C E, Cystatin C Calibrator, 1 x 1 mL, , UDI: (01)07090038460092 |
1051 | 07090038460108 | Gentian C E Calibrator Kit, 6 x 1 mL, , UDI: (01)07090038460108 |
1051 | 17090038460037 | Gentian C E, BCI Ref: A52763, Cystatin C calibrator Kit, 6 x 1 mL, , (01)17090038460037 |
8012 | Gentian C E, Cystatin C Calibrator, 1 x 1 mL, (Not distributed in US) |
- Lot codes and dates
Lot numbers #s: 1905415190440419044031809403
- Amount recalled
- 107 calibrator kits
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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