Z-1906-2019Class II

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

Name: Z-1906-2019 EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A
Creator: Bio-Rad Laboratories, Inc
Published: 2019-01-10
License: https://open.fda.gov/license/

Bio-Rad Laboratories Inc. / initiated 2019-01-10 / Open, Classified / root cause: software

FDA source

Bio-Rad Laboratories, Inc began a recall of EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A on 2019-01-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1906-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-01-10
Posted: 2019-06-30
Recalling firm: Bio-Rad Laboratories Inc.
Product: EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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).
Root cause tag: software
FDA root cause: Software design
Action: The recalling firm issued letters dated 1/9/2019 via FedEx on 1/10/2019 to all EVOLIS customers.
Quantity in commerce: 213 devices
Distribution: Distribution was nationwide to medical facilities, including to Puerto Rico. There was also government/military distribution. There was no foreign distribution.
Product codes and lots: Software version 1.4, UDI for the software is 03610520562024.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1906-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1906-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-07-10	2019-06-30

Product code JJE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)