BioMerieux SA: Medical Device Recall in 2018 - (Recall #: Z-0218-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

NucliSENS¿ Magnetic Extraction Reagents

Product Classification:

Class II

Date Initiated: September 17, 2018

Date Posted: October 31, 2018

Recall Number: Z-0218-2019

Event ID: 81067

Reason for Recall:

Data loggers showed that one shipment to the United States experienced low temperatures that may impact performance of this product.

Status: Terminated

Product Quantity: 42 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated