FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, Part Number: 447070, Lot Number: M908398 & M911529. Rheumatoid Factor (RF) Reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 5 Plus, is intended for the quantitative determination of rheumatoid factor in human serum or plasma by rate nephelometry.
- Recall number
- Z-2887-2011
- Recalling firm
- Beckman Coulter Inc.
- Product
- IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, Part Number: 447070, Lot Number: M908398 & M911529. Rheumatoid Factor (RF) Reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 5 Plus, is intended for the quantitative determination of rheumatoid factor in human serum or plasma by rate nephelometry.
- Status
- Terminated
- Initiated
- 2011-05-31
- Posted
- 2011-07-27
- Terminated
- 2013-06-03
- Reason
- 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.
- Root cause
- Pending
- Action
- 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.
- Quantity
- 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, Macao, Malaysia, Mexico, Netherlands, New Zealand, Oman, Pakistan, Poland, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, and United Kingdom.
- Lot, serial or model codes
- Lot Number: M908398 & M911529
- 510(k) numbers
- ["K963048"]
- PMA numbers
- not on file
- Product code
- DHR
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28