—#112693

Product

IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.

FDA product code: DHR — System, Test, Rheumatoid Factor
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K963048
Affected lot / code info: Lot# M012376 and M101865

Why it was recalled

The recall was initiated because Beckman Coulter has confirmed customer reports of QC shifts, lot-to-lot variation, and an increase in the percent of patient samples recovering >20 IU/mL using the Lots# M012376 and M101865 of IMMAGE RF reagent. The lots identified for the RF reagent might produce false abnormal results.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The firm, Beckman Coulter, sent an "URGENT PRODUCT CORRECTION" letter dated January 27, 2012 with an attached PCA Response Form to all customers who purchased the IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent. The letter describes the product, problem and actions to be taken. The customers were instructed to discontinue use of IMMAGE RF reagent lots M012376 and M101865; call Order Assistance at (800) 526-3821 in the United States, (800) 463-7828 in Canada or contact your local Beckman Coulter representative for replacements; and complete and return the enclosed FAX BACK RESPONSE FORM within 10 days via mail at: Beckman Coulter, Inc., 250 S. Kraemer Blvd, Mail Stop A2.0246, Brea, CA 92822-8000; Attn: Regulatory Affairs or fax to: (714) 961-4234. Note: Beckman Coulter has added additional release testing that will assure future lots RF will meet the reference interval claim of the IMMAGE RF Instructions for Use (IFU). If you have any questions concerning this letter, contact Beckman Coulter Support Center (call Center) on the Beckman Coulter Website at: http://www.beckmancoulter.com/customersupport/support/ or call (800) 854-3633 in the US and Canada. Outside of the US and Canada, customers were instructed to contact their local Beckman Coulter Representative.

Recalling firm

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

Distribution

Distribution pattern: Worldwide distribution: USA (nationwide) and country of: Canada.

Timeline

Recall initiated: 2012-01-27
Posted by FDA: 2012-10-01
Terminated: 2013-05-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #112693. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.