Date Initiated by Firm |
December 10, 2019 |
Create Date |
February 07, 2020 |
Recall Status1 |
Terminated 3 on February 16, 2021 |
Recall Number |
Z-1107-2020 |
Recall Event ID |
84439 |
510(K)Number |
K923122
|
Product Classification |
Enzyme linked immunoabsorbent assay, varicella-zoster - Product Code LFY
|
Product |
VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit |
Code Information |
US Model 30217-01 Lot 1007410330 and 1007393380 |
Recalling Firm/ Manufacturer |
bioMerieux, Inc. 100 Rodolphe St Durham NC 27712-9402
|
For Additional Information Contact |
Anne St¿phanie GUIGNOT 919-620-2000
|
Manufacturer Reason for Recall |
Two batches of VIDAS Varicella-Zoster IgG (VZG ref 30217) may yield an invalid calibration which may delay the patient's sample result or a valid calibration may lead to a false positive patient result.
|
FDA Determined Cause 2 |
Unknown/Undetermined by firm |
Action |
Users are instructed via customer letter to stop using the VIDAS¿ VZG batches 1007410330 and 1007393380 and destroy the remaining products. |
Quantity in Commerce |
1,218 US units total (726 US, 492 OUS) |
Distribution |
Distributed nationwide and 9 units to Biomerieux Canada. |
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 = LFY and Original Applicant = BIOMERIEUX VITEK, INC.
|