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

Is my product affected?

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

• UPC 03610520562024

Check against the official notice below — it lists the full affected range.

What happened

Bio-Rad Laboratories is recalling 213 units of the EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software (Catalog no. 90471A), specifically software version 1.4 (UDI 03610520562024). The system can fail to properly handle repeat testing requests and results under certain user-induced circumstances, potentially causing erroneous results to be transmitted to customers' Laboratory Information Systems.

The recalled devices were distributed nationwide to medical facilities and government/military locations, including Puerto Rico. The recall record does not specify a remedy or corrective action.

Written by software from the official notice below. Not reviewed by a lawyer.

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).

Details from the source

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). Distribution: Distribution was nationwide to medical facilities, including to Puerto Rico. There was also government/military distribution. There was no foreign distribution. Quantity: 213 devices Lot/code info: Software version 1.4, UDI for the software is 03610520562024.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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