—#107339

Product

Synchron CX Immuno-Protein Cal, part number: 442840, other product code: CKA The Beckman Coulter SYNCHRON CX Immune Protein Calibrator Set, in conjunction with SYNCHRON Immuno Protein Reagents, is intended for use on SYNCHRON CX Systems for the calibration of IgA, IgG, IgM, and Transferrin (TRF).

FDA product code: JIT — Calibrator, Secondary
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K883181
Affected lot / code info: Lot Number: M901330 and higher Other Lot numbers: M706000, M801451, M808220

Why it was recalled

A recall was initiated because Beckman has confirmed that the standardization of the Immuno Protein Calibrator Set has been re-established to IFCC Reference Preparation for Plasma Proteins, BCR-470 beginning with lot number M901330.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Beckman Coulter sent an Urgent Field Safety Notice letter dated August 24, 2009, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to share the information with their laboratory staff and retain the notification as part of their laboratory Quality System documentation. Customers with questions regarding the product correction action were instructed to contact their local Beckman Coulter Representative. For questions regarding this recall call 714-993-8916.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and Canada

Timeline

Recall initiated: 2009-08-26
Posted by FDA: 2012-03-20
Terminated: 2012-04-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107339. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.