Reported Jun 18, 2014 · Terminated
Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay…
Beckman Coulter 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: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 800 and UniCel DxI 600, UniCel DxC 600i, and the UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i, and UniCel DxC 660i systems.
- Lot codes and dates
- Access 2 Immunoassay Systems
- Catalog Number81600N. UniCel DxI 600 Access Immunoassay Systems
- Catalog NumbersA30260 and A71460. UniCel DxI 800 Access Immunoassay Systems
- Catalog Numbers973100 and A71456. UniCel DxC 600i SYNCHRON Access Clinical Systems
- Catalog NumberA25640. Catalog numbers for these systems are included in the respective
- DxI 600 and DxI 800 model numbersUniCel DxC 660i SYNCHRON Access Clinical Systems, UniCel DxC 680i SYNCHRON Access Clinical Systems, UniCel DxC 860i SYNCHRON Access Clinical Systems, UniCel DxC 880i SYNCHRON Access Clinical Systems
- Amount recalled
- 82 units
Where it was sold
- Nationwide
Why it was recalled
Beckman Coulter is initiating a field action because some Ultrasonic Transducer Kits were potentially assembled with incorrect mounting screws.
This product could cause temporary or reversible health problems — stop using it.
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