FDA recall Z-1109-2022

Product

VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021

Reason for recall

Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.

Distribution

US

Key facts

Status

Ongoing

Initiation date

2022-02-15

Report date

2022-05-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northbrook, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1109-2022