—#99589

Product

SYNCHRON Systems Calibrator 1, Part Numbers: 468405, Lots prior to M005558 The Beckman Coulter SYNCHRON Calibrator 1 (CAL 1), used in conjunction with SYNCHRON reagents, is intended for the calibration of immunoprotein tests on SYNCHRON LX and UniCel DxC Systems.

FDA product code: JIT — Calibrator, Secondary
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K965108
Affected lot / code info: Lots prior to M005558

Why it was recalled

The recall was initiated because standardization of the Synchron Systems Calibrator 1, used for both the Synchron LX and UniCel DxC systems, has been established to the new IFCC Reference Preparation for Plasma Proteins, ERM-DA470k (formerly CR470) beginning with lot number M005558. During the standardization to the new IFCC standard, ERM-DA470k, we confirmed that Complement C4 (C4) had been re

Root cause (FDA determination)

Pending

Action the firm took

Beckman Coulter initiated a Product Corrective Action (PCA) letter on the week of March 14, 2011, to the affected customers. Though Beckman is recalling the LX Cal 1, the recall letter was sent to the C4 reagent customers, as these are the only customers who will be impacted by the problem noted in the PCA letter. The letter provided the customers with an explanation of the problem identified and an action to be taken. The letter recommended consignees take the following actions: (1)Notify their clients to review and evaluate the impact on patients whose Complement C4 recovered near the clinical decision points. (2) Re-evaluate their laboratory's reference ranges for C4. The letter further requested that consignees share this information with laboratory staff and retain this notification as part of your laboratory Quality System documentation. Questions regarding this Product Announcement letter, or requests for the correlation graphs should be directed to Customer Support Center (Call Center) on the Beckman Coulter website at www.BeckmanCoulter.com/Customer Support/Support Request or call (800) 854-3633 in the United States and Canada.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and the countries of Argentina, Australia, Belgium, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Czech Republic, Denmark, Eritrea, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Republic of Kuwait, Lebanon, Lithuania, Malaysia, Mexico, Namibia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Poland, Puerto Rico, Qatar Reunion, Russian Federation, Rwanda, Serbia, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, and Viet Nam

Timeline

Recall initiated: 2011-03-11
Posted by FDA: 2011-05-20
Terminated: 2012-05-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99589. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.