Recall Z-0265-05 ยท CGN Acid, Folic, Radioimmunoassay
Beckman Coulter Inc
Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer.
| Date | Nov 30, 2004 (initiated Nov 8, 2004) |
| Status | Terminated |
| Reason | A rare condition of the Access 2 Immunoassay Systems software versions 2.0, 2.1 and 2.2 could present a risk of an erroneous confirmatory result under a specific set of circumstances. The Chlamydia Blocking results may be affected. The instrument will erroneously perform the blocking calculation on the affected test by using the mean of the diluted and neat results. |
| Root cause | Other |
| Action | Product Corrective Action (PCA) letter that informs customers (who ordered Access Chlamydia reagent in the past 24 months and have an Access 2 Immunoassay System) of this potential issue sent via US mail on November 8, 2004. The letter instructs customers to use unique Sample IDs for all samples assayed on the system - including those which have been manipulated offline prior to assay. A Technical Information Update will be issued to inform all support personnel of this issue. |
| Quantity | 1,197 |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K922823 | ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS Bio-Rad Laboratories, Inc., Aug 5, 1992 |