Z-1107-2020Class II

VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit

Name: Z-1107-2020 VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
Creator: bioMerieux, Inc.
Published: 2019-12-10
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2019-12-10 / Terminated / root cause: manufacturing process

FDA source

bioMerieux, Inc. began a recall of VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit on 2019-12-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1107-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-10
Posted: 2020-02-07
Terminated: 2021-02-16
Recalling firm: bioMerieux, Inc.
Product: VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit
Product code: LFY Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 1,218 US units total (726 US, 492 OUS)
Distribution: Distributed nationwide and 9 units to Biomerieux Canada.
Product codes and lots: US Model 30217-01 Lot 1007410330 and 1007393380

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1107-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1107-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-19	2020-02-07

Product code LFY

K923122Class IIVitek Immunodiagnostic Assay SystemBiomerieux Vitek, Inc. / cleared 1992-10-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)