Lower riskMedical device recall · FDA · Published January 10, 2019
Bio-Rad EVOLIS Microplate System Recall: Erroneous Lab Results Risk
Bio-Rad recalls EVOLIS Microplate System with TimeLiner software due to potential for incorrect lab results. Affected units may need correction to prevent errors in laboratory testing.
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).
Take action
Contact the company
📍Recalling firmBio-Rad Laboratories, Inc6565 185th Ave Ne · Redmond, WA 98052-5039
“Bio-Rad EVOLIS Microplate System Recall: Erroneous Lab Results Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69135-bio-rad-evolis-microplate-system-recall-erroneous-lab-results-risk. Based on FDA recall #Z-1906-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1906-2019%22&limit=1).
The Food and Drug Administration announced on Jan. 10, 2019, that Bio-Rad Laboratories, Inc. is recalling the EVOLIS Microplate System with TimeLiner Data Management Software due to a risk of transmitting erroneous results to customer laboratory information systems.
How to tell if you have it
EVOLIS Microplate System (Catalog no. 89700)
TimeLiner Data Management Software (Catalog no. 90471A)
Software version 1.4
UDI for the software is 03610520562024
The hazard
According to the FDA, user-induced circumstances can contribute to the EVOLIS Microplate Processor System not handling repeat testing requests or results properly. This malfunction may contribute to transmitting erroneous results to the customer's Laboratory Information System (LIS).
Context
GovInfoNow's records show Bio-Rad Laboratories, Inc. has 12 other recalls on record since April 2, 2018. Other recent recalls of similar products include Bio-Rad Platelia Toxo IgM Kit Recall (May 30, 2025), Bio-Rad BioPlex 220 Recall (Feb. 28, 2023), and Bio-Rad BioPlex 2200 Anti-CCP Calibrator Set Recall (Feb. 21, 2023). Other recent recalls of similar products include Vivoo Protein Test Recall (Nov. 22, 2025), Vivoo Test Strips Recall (Nov. 22, 2025), and Vivoo Vaginal pH Test Recall (Nov. 22, 2025).
How to tell if you have this one
Check for the product catalog number 89700 for the microplate system and catalog number 90471A for the TimeLiner software. The software version should be 1.4 or newer with the UDI 03610520562024.
Brand
Bio-Rad
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Software Version
Verify the TimeLiner software version is 1.4 or newer with the UDI 03610520562024.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Distribution was nationwide to medical facilities, including to Puerto Rico. There was also government/military distribution. There was no foreign distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 6 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1906-2019 (January 10, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1906-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.