FDA recall Z-1107-2020

Product

VIDAS Varicella Zoster IgG (VZG) antibody IVD, kit

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.

Key facts

Status

Terminated

Initiation date

2019-12-10

Report date

2020-02-19

Termination date

2021-02-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Durham, NC, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1107-2020