Z-1370-05

ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter

Name: Z-1370-05 ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter
Creator: Roche Diagnostics Corp.
Published: 2005-06-07
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2005-06-07 / Terminated

FDA source

Roche Diagnostics Corp. began a recall of ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter on 2005-06-07. 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, and held upwards, while the meter is waiting for the sample". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1370-05
Status: Terminated
Initiated: 2005-06-07
Posted: 2005-08-13
Terminated: 2007-07-02
Recalling firm: Roche Diagnostics GmbH
Product: ACCU-CHEK Go Care Kit; Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter.
Product code: NBW System, Test, Blood Glucose, Over The Counter
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, and held upwards, while the meter is waiting for the sample.
FDA root cause: Other
Action: Recall letters dated 6/7/05 were sent to all customers. Distributors were requested to send a copy of the notification to all customers of test strips used with the product. Users are instructed to never operate the meter without the optics cover in place, and this information will be included in test strip boxes.
Quantity in commerce: 2490
Distribution: Nationwide.
Product codes and lots: All units.

Product code NBW

K040796Class IIAccu-Chek Go SystemRoche Diagnostics Corp. / cleared 2004-04-22

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)