Recall Z-1194-2012
Beckman Coulter Inc. · initiated June 20, 2011
Product
SYNCHRON Rheumatoid Factor (RF) Reagent, Part Number: 475136 A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues.
Codes / lots: All in-date lots
Reason for recall
The recall was initiated because Beckman has confirmed that the all in date lots of Synchron Rheumatoid Factor (RF) Reagent might generate false positive results or calibration failures.
FDA-determined cause: Nonconforming Material/Component
Action taken
Beckman Coulter sent an Urgent Field Safety Notice/Product Correction letter dated June 20, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that Beckman Coulter is developing a new RF assay. In the meantime due to current issues related to shelf life and low end sensitivity, Beckman has decided to take the product off the market effective immediately. Beckman will keep the customers updated on their progress and advise when the new assay becomes available. Customers were instructed to complete and return the enclosed Response Form with in 10 days. Customers with questions regarding this notice can contact their local Beckman Sales representative or contact Customer Support Center at www.BeckmanCoulter.com/CustomerSupport/Support or call (800) 854-3633 in the US and Canada.
Details
- Recall number
- Z-1194-2012
- Initiated
- June 20, 2011
- Posted by FDA
- March 8, 2012
- Terminated
- September 2, 2014
- Product code
- DHR – System, Test, Rheumatoid Factor
- Quantity
- 22,081 units total (12,462 units in US)
- Distribution
- Worldwide Distribution - USA (nationwide) and worldwide to foreign countries: Australia, Belgium, China, Costa Rica, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Macao, Mexico, Netherlands, New Zealand, Poland, Russian Federation, Serbia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Turkey…
- Recalling firm
- Beckman Coulter Inc., Brea, CA