FDA recall Z-1311-2024

Product

Sekisui Diagnostics Control Kit OSOM¿ BVBLUE¿ Bacterial Vaginosis

Reason for recall

Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes .

Distribution

US Nationwide distribution in the states of AZ, PA and TX.

Key facts

Status

Ongoing

Initiation date

2024-01-09

Report date

2024-03-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Richmond, VA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1311-2024