VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
- Company
- Biomerieux, Inc.
- Recall Initiated
- December 10, 2019
- Terminated
- February 16, 2021
- Recall Number
- Z-1107-2020
- Quantity
- 1,218 US units total (726 US, 492 OUS)
- Firm Location
- Durham, NC
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.
Distribution
Distributed nationwide and 9 units to Biomerieux Canada.
Lot / Code Info
US Model 30217-01 Lot 1007410330 and 1007393380
Root Cause
Unknown/Undetermined by firm
Action Taken
Users are instructed via customer letter to stop using the VIDAS VZG batches 1007410330 and 1007393380 and destroy the remaining products.
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