Z-0883-05

Roche brand AccuData GTS/GTS Plus System Replacement Base/Module; Catalog number 3426050, material number...

Name: Z-0883-05 Roche brand AccuData GTS/GTS Plus System Replacement Base/Module; Catalog number 3426050, material number...
Creator: Roche Diagnostics Corp.
Published: 2005-04-18
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2005-04-18 / Terminated / root cause: packaging

FDA source

Roche Diagnostics Corp. began a recall of Roche brand AccuData GTS/GTS Plus System Replacement Base/Module; Catalog number 3426050, material number 03426050001 on 2005-04-18. The reason FDA records is "If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0883-05
Status: Terminated
Initiated: 2005-04-18
Posted: 2005-06-11
Terminated: 2006-03-07
Recalling firm: Roche Diagnostics GmbH
Product: Roche brand AccuData GTS/GTS Plus System Replacement Base/Module; Catalog number 3426050, material number 03426050001.
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: If foil wrapped packages or other metallic objects are lodged behind the supply drawer, an electrical short may result and high heat generated; this could result in plastic melting and battery leakage for customers using 'C' cell batteries to power their base and could render the system inoperable (system won't turn on) for customers using the A/C adaptor without batteries.
Root cause tag: packaging
FDA root cause: Other
Action: Consignees were notified via letter dated 4/18/05, which included instructions on how to inspect their unit for damage, and how to prevent future damage.
Distribution: Nationwide and Guam.
Product codes and lots: All units.

Product code CGA

K924475Class IIAccudata Glucose Test StationBoehringer Mannheim Corp. / cleared 1992-10-13

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)