—#107473

Product

SYNCHRON Rheumatoid Factor (RF) Reagent, Part Number: 475136 A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues.

FDA product code: DHR — System, Test, Rheumatoid Factor
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K971788
Affected lot / code info: All in-date lots

Why it was recalled

The recall was initiated because Beckman has confirmed that the all in date lots of Synchron Rheumatoid Factor (RF) Reagent might generate false positive results or calibration failures.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Beckman Coulter sent an Urgent Field Safety Notice/Product Correction letter dated June 20, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that Beckman Coulter is developing a new RF assay. In the meantime due to current issues related to shelf life and low end sensitivity, Beckman has decided to take the product off the market effective immediately. Beckman will keep the customers updated on their progress and advise when the new assay becomes available. Customers were instructed to complete and return the enclosed Response Form with in 10 days. Customers with questions regarding this notice can contact their local Beckman Sales representative or contact Customer Support Center at www.BeckmanCoulter.com/CustomerSupport/Support or call (800) 854-3633 in the US 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 worldwide to foreign countries: Australia, Belgium, China, Costa Rica, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Macao, Mexico, Netherlands, New Zealand, Poland, Russian Federation, Serbia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Turkey, United Arab Emirates, and the United Kingdom.

Timeline

Recall initiated: 2011-06-20
Posted by FDA: 2012-03-08
Terminated: 2014-09-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #107473. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.