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Terminated

Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122.

FDA Recall Z-1550-06 · Posted 2006-09-29

Recalling FirmRoche Diagnostics Corp.
Recall StatusTerminated
Product CodeCGN
Date Initiated2006-09-15
Date Terminated2008-04-30
Product Quantity5688 units

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K043318MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAYRoche Diagnostics Corp. · 2004-12-23

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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