Device product
NucliSENS¿ Magnetic Extraction Reagents
Z-0218-2019
Product summary
- Firm
- BioMerieux SA
- Event
- Event 81067
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42 units
- Official record key
device-enforcement:Z-0218-2019
Official wording
Reason: Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.
Code information: Reference # 200293, Lot # 17121501, Expiration date 11/28/2018
Distribution pattern: Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA.
Derived failure modes
-
Unknown
Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.