Recall Z-1833-2017
Beckman Coulter Inc. · initiated March 10, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Access Ferritin Calibrators, Part No. 33025, Ref No. B50136C
Codes / lots: Lot No. 671094
Reason for recall
Beckman Coulter is recalling the Access Ferritin Calibrators kit because it contains a calibration card with an incorrect S5 calibrator concentration.
FDA-determined cause: Other
Action taken
Beckman Coulter sent an Urgent Medical Device Recall letter dated March 10, 2017, to inform them that Beckman Coulter has determined through customer feedback that a portion of the Access Ferritin Calibrators kit lot listed above contains a calibration card with an incorrect S5 calibrator concentration. The S5 concentration value printed on the card and encoded in the barcode is 1.500 (ng/mL) rather than the correct concentration of 1500 (ng/mL). Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to contact Customer Technical Support Center via http://www.beckmancoulter.com/customersupport/support, call 1-800-854-3633 the US and Canada and customers outside the US and Canada are instructed to contact their local Beckman Coulter Representative.
Details
- Recall number
- Z-1833-2017
- Initiated
- March 10, 2017
- Posted by FDA
- April 17, 2017
- Terminated
- June 27, 2017
- Product code
- JMG – Radioimmunoassay (Two-Site Solid Phase), Ferritin
- Quantity
- 889 kits total (6 kits in US)
- Distribution
- Worldwide Distribution - US Distribution and to the countries of : Algeria, Bangladesh, Belgium, Botswana, Croatia, Czech Republic, Denmark, Djibouti, Egypt, France, Germany, Ghana, Greece, Hungary, Ireland, Italy, Kazakhstan, Lebanon, Lithuania, Morocco, Nepal, Netherlands, Oman, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland…
- Recalling firm
- Beckman Coulter Inc., Brea, CA