Recall Z-0812-2023— Biomerieux Inc
Class II · Ongoing
Class II FDA medical device recall by Biomerieux Inc, initiated 2022-11-09. FDA's recall record names no specific 510(k) clearance for this event. Product: ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016. Reason: As the temperature and time out of range was exceeded, product performances cannot be guaranteed.
- Recalling firm
- Biomerieux Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-11-09
- Firm location
- Hazelwood, MO, United States
Product description
ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016
Reason for recall
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Data sourced from openFDA. This site is unofficial and independent of the FDA.