Z-0574-06

Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216

Name: Z-0574-06 Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216
Creator: Roche Diagnostics Corp.
Published: 2006-02-10
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2006-02-10 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216 on 2006-02-10. The reason FDA records is "May have tobramycin over-recovery at the trough level". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0574-06
Status: Terminated
Initiated: 2006-02-10
Posted: 2006-02-28
Terminated: 2006-06-23
Recalling firm: Roche Diagnostics GmbH
Product: Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216.
Product code: LFW Fluorescence Polarization Immunoassay, Tobramycin
Reason for recall: May have tobramycin over-recovery at the trough level.
FDA root cause: Other
Action: Consignees were notified via phone and faxed recall letter on or about 2/10/06.
Quantity in commerce: 1806 kits
Distribution: Nationwide.
Product codes and lots: Lot 56292625; exp. 05/31/07.

Product code LFW

K912143Class IICedia(r) Tobramycin AssayMicrogenics Corp. / cleared 1991-07-26

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)