Bio-Rad Laboratories, Inc recalls EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.

Recall date

January 10, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1906-2019

FDA classification

Class II

Brand / firm

Bio-Rad Laboratories, Inc

Sold / distributed

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

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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