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U.S. Department of Health and Human Services

Class 2 Device Recall Gentian Cystatin C Immunoassay

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  Class 2 Device Recall Gentian Cystatin C Immunoassay see related information
Date Initiated by Firm September 02, 2020
Create Date October 13, 2020
Recall Status1 Terminated 3 on September 28, 2022
Recall Number Z-0099-2021
Recall Event ID 86465
510(K)Number K071388  K081875  
Product Classification Test, cystatin c - Product Code NDY
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)
Code Information Lot numbers #s: 1905415,1904404,1904403,1809403
Recalling Firm/
Manufacturer		 Gentian AS
Bjornasveien 5
Moss Norway
Manufacturer 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 2		 Under Investigation by firm
Action 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.
Quantity in Commerce 107 calibrator kits
Distribution US: MN, VA, KS,
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = NDY and Original Applicant = GENTIAN AS
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