Z-1385-06

Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 11931601216)...

Name: Z-1385-06 Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 11931601216)...
Creator: Roche Diagnostics Corp.
Published: 2006-07-25
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2006-07-25 / Terminated / root cause: labeling and UDI

FDA source

Roche Diagnostics Corp. began a recall of Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 11931601216) Lot No. 674653 on 2006-07-25. The reason FDA records is "The vial containing the R2 reagent is labeled as R1 reagent and if placed in the R1 slot of the analyzer, erroneous results will be obtained. (extremely low patient and control results)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1385-06
Status: Terminated
Initiated: 2006-07-25
Posted: 2006-08-09
Terminated: 2007-04-18
Recalling firm: Roche Diagnostics GmbH
Product: Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit; Catalog No. 1931601 (Roche Material No. 11931601216) Lot No. 674653
Product code: GTQ Antistreptolysin - Titer/Streptolysin O Reagent
Reason for recall: The vial containing the R2 reagent is labeled as R1 reagent and if placed in the R1 slot of the analyzer, erroneous results will be obtained. (extremely low patient and control results)
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified via recall letter dated 7/25/06 to cease using and to discard the product.
Quantity in commerce: 20 kits.
Distribution: Nationwide including the states of Arizona, California, New Jersey and Pennsylvania.
Product codes and lots: Lot 674653; exp. 12/31/2006.

Product code GTQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)