bioMerieux Recalls VIDAS Varicella Zoster IgG Antibody Test Kits
bioMerieux is recalling VIDAS Varicella Zoster IgG antibody kits due to potential invalid calibrations or false positive results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of false positive results, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
bioMerieux, Inc. is recalling two batches of VIDAS Varicella Zoster IgG (VZG) antibody IVD kits. The affected products are US Model 30217-01, specifically Lot 1007410330 and Lot 1007393380. A total of 1,218 units were distributed, including 726 units in the United States and 492 units outside the US, with 9 units sent to Biomerieux Canada.
The recall was initiated because the test kits may yield an invalid calibration, which could delay patient sample results. Alternatively, a valid calibration may lead to a false positive patient result. The agency has classified this as a Class II recall.
Healthcare facilities and laboratories that have received these specific lots should stop using the affected kits and contact bioMerieux for instructions on returning or disposing of the product. Patients who have received test results using these kits should consult their healthcare provider if they have concerns about the accuracy of their results.
The recalled product
- Product
- VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
- Manufacturer
- bioMerieux, Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- US Model 30217-01 Lot 1007410330 and 1007393380
Distribution
Distributed nationwide across the United States.
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