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U.S. Department of Health and Human Services

Class 2 Device Recall Access Immunoassay Systems Hybritech free PSA Calibrator

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 Class 2 Device Recall Access Immunoassay Systems Hybritech free PSA Calibratorsee related information
Date Initiated by FirmJanuary 08, 2008
Date PostedSeptember 16, 2009
Recall Status1 Terminated 3 on November 29, 2011
Recall NumberZ-2220-2009
Recall Event ID 48960
PMA NumberP970038S004 
Product Classification Test,prostate specific antigen,free,(noncomplexed) to distinguish prostate cancer from benign condit - Product Code MTG
ProductBeckman Coulter Access Hybritech free PSA Calibrators, REF 37215. The Access Hybritech free PSA assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (PSA) in human serum using the Access Immunoassay System.
Code Information Part Number: 37215, Lot Number: 715293.
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact
714-993-5321 Ext. 8383
Manufacturer Reason
for Recall		Beckman Coulter incorrectly shipped Access Hybritech free PSA calibrators containing dual calibration cards (Hybritech and WHO) to your lab. The WHO calibration for free PSA is marketed without a PMA.
FDA Determined
Cause 2		Other
ActionBeckman Coulter contacted customers by phone beginning January 11, 2009 and sending a Product Corrective Action letter informing them to discontinue use and discard the referenced product immediately. For further information, contact Customer Technical Support at 1-800-854-3633 or contact your local Beckman Coulter Representative.
Quantity in Commerce22 Kits
DistributionNationwide Distribution -- OH, CA, TX, OR, MD, MO, FL and PA.
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.
PMA DatabasePMAs with Product Code = MTG
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