EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
Reported: July 10, 2019 Initiated: January 10, 2019 #Z-1906-2019
Product Description
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.
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).
Details
- Recalling Firm
- Bio-Rad Laboratories, Inc
- Units Affected
- 213 devices
- Distribution
- Distribution was nationwide to medical facilities, including to Puerto Rico. There was also government/military distribution. There was no foreign distribution.
- Location
- Redmond, WA
Frequently Asked Questions
What product was recalled? ▼
EVOLIS Microplate System (Catalog no. 89700) with TimeLiner Data Management Software, (Catalog no. 90471A.. Recalled by Bio-Rad Laboratories, Inc. Units affected: 213 devices.
Why was this product 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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 10, 2019. Severity: Moderate. Recall number: Z-1906-2019.
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