Recall Z-1550-06 ยท CGN Acid, Folic, Radioimmunoassay
Roche Diagnostics Corp.
Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122.
| Date | Sep 29, 2006 (initiated Sep 15, 2006) |
| Status | Terminated |
| Reason | Gel-like particle formation; may result in a clot settling in the analyzer measuring cell, which will create a low signal and may cause incorrectly high or low QC and/or patient results depending on the assay method. |
| Root cause | Other |
| Action | Consignees were informed via letter dated 9/15/06 to perform Folate assays in batch mode and to run controls and liquid flow cleaning upon completion of each batch run. Distributors were requested to notify their customers. |
| Quantity | 5688 units |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043318 | MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY Roche Diagnostics Corp., Dec 23, 2004 |