Biomerieux Inc: Medical Device Recall in 2023 - (Recall #: Z-0812-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

ASTUTE REAGENT ASTUTE ELECTRONIC QUALITY CTRL DEVICE US, CATALOG 400016

Product Classification:

Class II

Date Initiated: November 9, 2022

Date Posted: January 11, 2023

Recall Number: Z-0812-2023

Event ID: 91148

Reason for Recall:

As the temperature and time out of range was exceeded, product performances cannot be guaranteed

Status: Ongoing

Product Quantity: 5 units

Code Information:

UDI/DI 03573026565541, Batch Numbers: 21EQC0163I, 21EQC0162I, 21EQC0160I, 21EQC0158I, 21EQC0174I

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated