bioMerieux, Inc.: Medical Device Recall in 2022 - (Recall #: Z-1564-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 20, 2022

Date Posted: August 31, 2022

Recall Number: Z-1564-2022

Event ID: 90596

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1,301 kits

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.

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.

Voluntary or Mandated:

Voluntary: Firm initiated