Reported Jul 10, 2019 · Ongoing
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
Bio-Rad Laboratories, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bio-Rad Laboratories, Inc · 6565 185th Ave Ne · Redmond, WA · 98052-5039
Is this the product you have?
- EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
- Lot codes and dates
Software version 1.4UDI for the software is 03610520562024
- Amount recalled
- 213 devices
Where it was sold
- Nationwide
- PR
Why it was recalled
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).
This product could cause temporary or reversible health problems — stop using it.
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