Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122.
FDA device recall Z-1550-06 · posted 2006-09-29 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CGN
- Quantity affected
- 5688 units
- Distribution
- Nationwide.
- Date initiated
- 2006-09-15
- Date posted
- 2006-09-29
- Date terminated
- 2008-04-30
- Location
- Indianapolis, IN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY (K043318) | Roche Diagnostics Corp. | 2004-12-23 |