IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, Part Number: 447070, Lot Number: M908398 & M911529. Rheum

FDA device recall Z-2887-2011 · posted 2011-07-27 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

Reason for recall

The recall was initiated because the listed lots of Rheumatoid Factor (RF) Reagent might produce false positive results. A false positive result might lead to additional unnecessary testing.

Action taken

Beckman Coulter sent an "URGENT FIELD SAFETY NOTICE/PRODUCT CORRECTION" letter dated May 31, 2011 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to discontinue use of the affected products. Customers were asked to complete and return an attached FAX BACK Response Form to 714-961-4234. Replacement products may be obtained by calling Order Assistance at 800-526-3821 in the United States, (800) 463-7828 in Canada or contacting your local Beckman Coulter representative. For any questions regarding this notice, contact the Customer Support Center (Call Center) on the Beckman Coulter website at www.BeckmanCoulter.com/CustomerSupport/Support or call (800) 854-3633 in the United States and Canada; or contact your local sales representative.

Root cause

Pending

Status

Terminated

Product code

DHR

Quantity affected

6302 units (850 in the US)

Distribution

Worldwide Distribution--USA (nationwide) and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, Kuwait

Date initiated

2011-05-31

Date posted

2011-07-27

Date terminated

2013-06-03

Location

Brea, CA

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