Recall Z-2220-2009 ยท MTG Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
Beckman Coulter Inc
Beckman 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.
| Date | Sep 16, 2009 (initiated Jan 8, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Beckman 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 | 22 Kits |
| Distribution | Nationwide Distribution -- OH, CA, TX, OR, MD, MO, FL and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.