Bio-Rad Laboratories, Inc: Medical Device Recall in 2019 - (Recall #: Z-1906-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.

Product Classification:

Class II

Date Initiated: January 10, 2019

Date Posted: July 10, 2019

Recall Number: Z-1906-2019

Event ID: 82920

Reason for Recall:

User-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling repeat testing requests/results properly and may contribute to transmitting erroneous results to the customer's Laboratory Information System (LIS).

Status: Ongoing

Product Quantity: 213 devices

Code Information:

Software version 1.4, UDI for the software is 03610520562024.

Distribution Pattern:

Distribution was nationwide to medical facilities, including to Puerto Rico. There was also government/military distribution. There was no foreign distribution.

Voluntary or Mandated:

Voluntary: Firm initiated