Recall Z-1743-2011 ยท DHR System, Test, Rheumatoid Factor
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.
| Date | Mar 22, 2011 (initiated Jun 21, 2010) |
| Status | Terminated |
| 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, In |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971788 | SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR Beckman Instruments, Inc., Jun 3, 1997 |