Z-1564-2022 Class II Ongoing

Recalled by bioMerieux, Inc. — Durham, NC

Recall Details

Product Type
Devices
Report Date
August 31, 2022
Initiation Date
July 20, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,301 kits

Product Description

NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.

Reason for Recall

There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.

Distribution Pattern

Distribution was made to AR, AZ, CA, CT, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, TN, TX, and VA. There was no government/military distribution.

Code Information

Lot numbers distributed in the U.S.: Z012MK1MS, exp. 28-NOV-2022; Z012ML1MS, exp. 28-NOV-2022; Z012NB1MS, exp. 28-DEC-2022; Z013AL1MS, exp. 28-JAN-2023. UDI: 03573026139339.