SYNCHRON System(s) Chemistry RF Rheumatoid Factor Part Number 475136 RF reagent, when used in conjunction with SYNCHRON
FDA device recall Z-1743-2011 · posted 2011-03-22 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DHR
- Quantity affected
- 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, Leba
- Date initiated
- 2010-06-21
- Date posted
- 2011-03-22
- Date terminated
- 2012-07-02
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR (K971788) | Beckman Instruments, Inc. | 1997-06-03 |