Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122.
Hazard
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.
What You Should Do
Remedy
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.
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Products
Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122.
- Brand
- Roche Diagnostics Corp.
- UPC
- Lots 175646 and 174558.
Units Affected
5688 units