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Bio-Rad Laboratories, Inc recalls EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
Recalled July 10, 2019 · FDA recall Z-1906-2019 · Bio-Rad Laboratories
Hazard
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). · FDA Class II
Units
213 devices
Sold at
Distribution was nationwide to medical facilities, including to Puerto Rico. There was also government/military distribution. There was no foreign distribution.
Description
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).
Product
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
Manufacturer(s)
Bio-Rad Laboratories, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →