Recalls / —
—#178325
Product
VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
- FDA product code
- LFY — Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
- Device class
- Class 2
- Medical specialty
- Microbiology
- 510(k) numbers
- K923122
- Affected lot / code info
- US Model 30217-01 Lot 1007410330 and 1007393380
Why it was recalled
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.
Root cause (FDA determination)
Unknown/Undetermined by firm
Action the firm took
Users are instructed via customer letter to stop using the VIDAS VZG batches 1007410330 and 1007393380 and destroy the remaining products.
Recalling firm
- Firm
- bioMerieux, Inc.
- Address
- 100 Rodolphe St, Durham, North Carolina 27712-9402
Distribution
- Distribution pattern
- Distributed nationwide and 9 units to Biomerieux Canada.
Timeline
- Recall initiated
- 2019-12-10
- Terminated
- 2021-02-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #178325. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.