Recall Z-1197-2009 ยท LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Beckman Coulter Inc
Beckman Coulter Access Immunoassay System Hybritech PSA Calibrators, Product Number: 37205. The Access Hybritech PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total prostate specific antigen (PSA) levels in human serum using the Access Immunoassay Systems.
| Date | Apr 28, 2009 (initiated Jan 8, 2008) |
| Status | Terminated |
| Reason | Beckman Coulter incorrectly shipped Access Hybritech PSA calibrators containing dual calibration cards (Hybritech and WHO) to some Access Hybritech PSA Customers. The WHO calibration for PSA is not currently approved in the United States. |
| Root cause | Packaging process control |
| Action | An "Urgent: Product Corrective Action" letter dated January 10, 2008 was issued via fax or mail to customers. The letter described the issue and instructed consignees to discontinue use and discard the affected product. Consignees were also asked to complete and return a "Fax-Back Form" via fax (1-952-368-7610) or mail to Beckman Coulter, Inc. within 10 days of receiving the notification letter. Further questions should be addressed to Beckman Coulter Customer Technical Support at 1-800-854-3633. |
| Quantity | 123 Units |
| Distribution | Nationwide Distribution -- Including states of AL, AZ, CA, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, NC, NY, OK, OR, PA, SC, TN, TX, VA, WI and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.