Recall Z-1107-2020 ยท LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
bioMerieux, Inc.
VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
| Date | Dec 10, 2019 |
| Status | Terminated |
| Reason | 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 | 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 | 1,218 US units total (726 US, 492 OUS) |
| Distribution | Distributed nationwide and 9 units to Biomerieux Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K923122 | VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM Biomerieux Vitek, Inc., Oct 26, 1992 |