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Recall Observatory FDA recall evidence

Device product

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

Z-1906-2019

January 10, 2019

Class II

Product summary

Firm
Bio-Rad Laboratories, Inc
Event
Event 82920
Status
Ongoing
Classification
Class II
Quantity
213 devices
Official record key
device-enforcement:Z-1906-2019

Official wording

Reason: 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).

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).