Recall Z-1645-2012 ยท MTG Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions
Beckman Coulter Inc.
Access Hybritech Free PSA, Part Number: 37210 Free PSA is used to aid in the differentiation between prostate cancer and benign prostatic conditions when total PSA levels are between 4 and 10 ng/mL.
| Date | May 22, 2012 (initiated Oct 11, 2011) |
| Status | Terminated |
| Reason | A recall was initiated because Beckman Coulter has confirmed a change to the recommended diluents for the Access Hybritech free PSA reagent. |
| Root cause | Process design |
| Action | Beckman Coulter sent a Product Correction letter dated October 11, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed regarding a change to the recommended diluents for the Access Hybritech free PSA reagent. Patient safety is not affected by this change. " Do not dilute elevated free PSA patient samples with Wash Buffer II. " Do not dilute elevated free PSA patient samples using the UniCel DxI onboard dilution feature. " Dilute elevated free PSA samples with Access Hybritech free PSA C |
| Quantity | 90,965 units total (24,951 units in US) |
| Distribution | Worldwide Distribution -- USA (nationwide ) and the countries of Algeria, Angola, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Bosnia, Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Djibouti, Ecuador, Egypt, El Salvador, Ethiopia, Finla |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.