—#101374

Product

SYNCHRON CX4 Clinical System Part #: 758300 Product Usage: The Beckman SYNCHRON CX4 DELTA, CX7 DELTA, CX4CE, and CX7 systems are fully automated and computer controlled instruments designed for the in vitro diagnostic quantitation of biological fluid components and therapeutic drugs as well as the qualitative determination of drugs of abuse in urine

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K881498
Affected lot / code info: All non-PRO Software Versions

Why it was recalled

The recall was initiated because Beckman Coulter has confirmed software limitations which affect only manually-loaded reagent cartridges on the CX4/5/7 CE, CX4/5/7 Delta and CX9 ALX Clinical Systems.

Root cause (FDA determination)

Software design

Action the firm took

Beckman Coulter sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated September 20, 2010 with an attached Fax Back Response Form (via US Postal Service for US Customers) to all customers who purchased the Synchron CX4/5/7 CE, CX4/5/7 Delta and CX9 ALX Clinical Systems. The letter provides the customers wtih an explanation of the problem identified and actions to be taken. Customers were instructed to share this information with laboratory staff and retain this notification as part of their laboratory Quality System documentation. If they forwarded the affected product listed above to another laboratory, they were asked to provide a copy of this letter to them. Questions regarding this Product Corrective Action letter, were directed to Customer Support Center (Call Center) on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the United States and Canada. Outside the United States and Canada, they were directed to their local Beckman Coulter Representative.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92822-6232

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and the country of Canada

Timeline

Recall initiated: 2010-08-23
Posted by FDA: 2011-10-27
Terminated: 2012-06-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #101374. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.