FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: SYNCHRON System(s) Chemistry RF Rheumatoid Factor Part Number 475136 RF reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems CAL 5 Plus, is intended for quantitative determination of Rheumatoid Factor concentration in human serum or plasma.
- Recall number
- Z-1743-2011
- Recalling firm
- Beckman Coulter Inc.
- Product
- SYNCHRON System(s) Chemistry RF Rheumatoid Factor Part Number 475136 RF reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems CAL 5 Plus, is intended for quantitative determination of Rheumatoid Factor concentration in human serum or plasma.
- Status
- Terminated
- Initiated
- 2010-06-21
- Posted
- 2011-03-22
- Terminated
- 2012-07-02
- Reason
- The recall was initiated because Beckman Coulter testing indicated that Rheumatoid Factor (RF) reagent lot M907325 will not remain stable to the labeled expiration date.
- Root cause
- Other
- Action
- The firm Beckman Coulter, sent a "URGENT: PRODUCT CORRECTIVE ACTION" letter dated June 25, 2010 to the consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to take the following actions: *Discontinue use and discard appropriately Rheumatoid Factor (RF) reagent lot M907325 *Contact their Customer Service Representative at (800) 526-3821 in the United States or (800) 463-7828 in Canada to discuss reagent replacement options. *Complete and return the FAX BACK RESPONSE FORM via fax to (714) 961-4234 or mail to: Beckman Coulter, Inc., Attn: Regulatory Affairs, 250 S. Kraemer Blvd., Brea, California 92821, Mail Code E2.SE.08 Consignees/customers were asked to share this information with laboratory staff and retain this notification as part of their laboratory Quality System documentation. If consignees/customers forwarded the affected products listed above to another laboratory, then they need to also provide a copy of the Product Corrective Action letter to the laboratory. If they have any questions regarding this Product Corrective Action letter, consignees were told to call Beckman Coulter Customer Support Center (Hotline) at (800) 854-633 in the United States and Canada.
- Quantity
- 58 units
- Distribution
- Worldwide distribution: USA including states of: AZ, CA, CO, IA, PA, NH, NV, NY, and WA; and countries of: Belgium, China, Czech Republic, France, Germany, Hong Kong, India, Italy, Japan, Kuwait, Lebanon, Lithuania, Mexico, Netherlands, Russian Federation, South Africa, Spain, Switzerland, Taiwan, Turkey, and United Kingdom.
- Lot, serial or model codes
- Lot #M907325
- 510(k) numbers
- ["K971788"]
- 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