Z-1550-06

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

Name: Z-1550-06 Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122
Creator: Roche Diagnostics Corp.
Published: 2006-09-15
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2006-09-15 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122 on 2006-09-15. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1550-06
Status: Terminated
Initiated: 2006-09-15
Posted: 2006-09-29
Terminated: 2008-04-30
Recalling firm: Roche Diagnostics GmbH
Product: Roche Elecsys Folate II for use on Elecsys 210 Analyzers; Catalog No. 3253678 (Roche Material No. 03253678122.
Product code: CGN Acid, Folic, Radioimmunoassay
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.
FDA root cause: Other
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.
Quantity in commerce: 5688 units
Distribution: Nationwide.
Product codes and lots: Lots 175646 and 174558.

Product code CGN

K043318Class IIModification to Roche Elecsys Folate II ImmunoassayRoche Diagnostics Corp. / cleared 2004-12-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)