—#48096

Product

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

FDA product code: CGN — Acid, Folic, Radioimmunoassay
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K043318
Affected lot / code info: Lots 175646 and 174558.

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Roche Diagnostics Corp.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

Distribution pattern: Nationwide.

Timeline

Recall initiated: 2006-09-15
Posted by FDA: 2006-09-29
Terminated: 2008-04-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #48096. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.