FDA Device recall Z-1906-2019
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A
- FDA Device
- Class II
- ongoing
- Published 2019-07-10
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
| Agency | FDA Device |
|---|---|
| Recall number | Z-1906-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-01-10 |
| Published | 2019-07-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Bio Rad Laboratories |
| Distribution | US |
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_info | Software 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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