Recall Z-2387-2017— Biomerieux Inc
Class II · Terminated
Class II FDA medical device recall by Biomerieux Inc, initiated 2017-04-20, terminated 2020-07-22. FDA's recall record names no specific 510(k) clearance for this event. Product: VITEK¿ 2 Gram Negative Susceptibility card (AST-N201), REF 412862, 20 cards per carton.. Reason: The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency)..
- Recalling firm
- Biomerieux Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-04-20
- Terminated
- 2020-07-22
- Firm location
- Hazelwood, MO, United States
Product description
VITEK¿ 2 Gram Negative Susceptibility card (AST-N201), REF 412862, 20 cards per carton.
Reason for recall
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
Data sourced from openFDA. This site is unofficial and independent of the FDA.