Recall Z-0218-2019— BioMerieux SA
Class II · Terminated
Class II FDA medical device recall by BioMerieux SA, initiated 2018-09-17, terminated 2020-05-18. FDA's recall record names no specific 510(k) clearance for this event. Product: NucliSENS¿ Magnetic Extraction Reagents. Reason: Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product..
- Recalling firm
- BioMerieux SA
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-17
- Terminated
- 2020-05-18
- Firm location
- Marcy L'Etoile, N/A, France
Product description
NucliSENS¿ Magnetic Extraction Reagents
Reason for recall
Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.