Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122.
This recall has been terminated (originally issued September 29, 2006).
- Company
- Roche Diagnostics Corp.
- Recall Initiated
- September 15, 2006
- Posted
- September 29, 2006
- Terminated
- April 30, 2008
- Recall Number
- Z-1550-06
- Quantity
- 5688 units
- Firm Location
- Indianapolis, IN
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide.
Lot / Code Info
Lots 175646 and 174558.
Root Cause
Other
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.
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