RecallRadar

FDA Device recall Z-1906-2019

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

On 2019-07-10 the FDA classified a Class II recall of EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A by Bio Rad Laboratories, citing user-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling repeat testing requests/results properly and may contribute to transmitting errone….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1906-2019
ClassificationClass II
Statusongoing
Initiated2019-01-10
Published2019-07-10
Last updated2026-09-13 11:55 UTC
CompanyBio Rad Laboratories
DistributionUS

Product

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

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).

Identifiers

code_infoSoftware version 1.4, UDI for the software is 03610520562024.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1906-2019%22

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