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U.S. Department of Health and Human Services

Class 2 Device Recall Access Ferritin Calibrators for Access Ferritin assay on the Access Immunoassay Systems

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 Class 2 Device Recall Access Ferritin Calibrators for Access Ferritin assay on the Access Immunoassay Systemssee related information
Date Initiated by FirmMarch 10, 2017
Date PostedApril 17, 2017
Recall Status1 Terminated 3 on June 27, 2017
Recall NumberZ-1833-2017
Recall Event ID 76838
510(K)NumberK052082 K926221 
Product Classification Radioimmunoassay (two-site solid phase), ferritin - Product Code JMG
ProductAccess Ferritin Calibrators, Part No. 33025, Ref No. B50136C
Code Information Lot No. 671094
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
Manufacturer 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 2		Other
ActionBeckman 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.
Quantity in Commerce889 kits total (6 kits in US)
DistributionWorldwide 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, Turkey, United Kingdom, and Zimbabwe.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JMG
510(K)s with Product Code = JMG
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