Z-0218-2019 Class II Terminated

Recalled by BioMerieux SA — Marcy L'Etoile, N/A

Recall Details

Product Type
Devices
Report Date
October 31, 2018
Initiation Date
September 17, 2018
Termination Date
May 18, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
42 units

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.

Distribution Pattern

Nationwide distribution to MD, TX, MA, GA, OH, OR, CA, and WA.

Code Information

Reference # 200293, Lot # 17121501, Expiration date 11/28/2018