Recall Z-0422-2022— Biomerieux Inc
Class II · Terminated
Class II FDA medical device recall by Biomerieux Inc, initiated 2021-11-09, terminated 2025-02-10. FDA's recall record names no specific 510(k) clearance for this event. Product: RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.. Reason: There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test..
- Recalling firm
- Biomerieux Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-11-09
- Terminated
- 2025-02-10
- Firm location
- Hazelwood, MO, United States
Product description
RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
Reason for recall
There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.
Data sourced from openFDA. This site is unofficial and independent of the FDA.