Z-0978-05

ACCU-CHEK Instant Meter; Catalog numbers 914 and 924

Name: Z-0978-05 ACCU-CHEK Instant Meter; Catalog numbers 914 and 924
Creator: Roche Diagnostics Corp.
Published: 2005-05-18
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2005-05-18 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of ACCU-CHEK Instant Meter; Catalog numbers 914 and 924 on 2005-05-18. The reason FDA records is "The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards while the meter is waiting for the sample or if the test strip...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0978-05
Status: Terminated
Initiated: 2005-05-18
Posted: 2005-07-13
Terminated: 2006-02-26
Recalling firm: Roche Diagnostics GmbH
Product: ACCU-CHEK Instant Meter; Catalog numbers 914 and 924.
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: The meter may self-start without a sample having been applied and report erroneous results without an error message if an undosed test strip is bent upwards while the meter is waiting for the sample or if the test strip opening has been previously flooded with excess control solution or blood.
FDA root cause: Other
Action: A recall letter dated 5/18/05 was sent to health care professionals informing them of the problem and reqeusting them to provide a letter to their patients alerting them to the issue and how to avoid it. A notice of the problem will be placed in all packages of strips in the future.
Distribution: Nationwide.
Product codes and lots: All units.

Product code CGA

K952875Class IIAccu-Chek Alpha Monitor & Accu-Chek Glucose Test StripsBoehringer Mannheim Corp. / cleared 1995-11-21

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)