Recall Z-0099-2021
Gentian AS · initiated September 2, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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)
Codes / lots: Lot numbers #s: 1905415,1904404,1904403,1809403
Reason for recall
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.
FDA-determined cause: Under Investigation by firm
Action taken
Gentian AS issued a "Field Safety Notice" letter on September 2, 2020 concerning the removal of the Gentian Cystatin C Calibrator and Calibrator Kit. In addition, to informing consignees about the recall the firm asked consignees to take the following actions: 1. Discontinue use of the affected lots listed in this Field Safety Notice 2. Please inform Gentian of remaining stock of the affected lots numbers given in this Field Safety Notice. 3. Share this notification with other relevant personnel in your organization and affected customers 4. Please sign and return this document by e-mail to confirm that this notification of withdrawal has been received and understood.
Details
- Recall number
- Z-0099-2021
- Initiated
- September 2, 2020
- Terminated
- September 28, 2022
- Product code
- NDY – Test, Cystatin C
- Quantity
- 107 calibrator kits
- Distribution
- US: MN, VA, KS,
- Recalling firm
- Gentian AS, Moss