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Open, Classified

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

FDA Recall Z-1906-2019 · Posted None

Recalling FirmBio-Rad Laboratories, Inc
Recall StatusOpen, Classified
Product CodeJJE
Date Initiated2019-01-10
Product Quantity213 devices

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).

Firm Action

The recalling firm issued letters dated 1/9/2019 via FedEx on 1/10/2019 to all EVOLIS customers.

Root Cause

Software design

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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