Z-1616-2014Class II

ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51...

Name: Z-1616-2014 ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51...
Creator: Roche Diagnostics Operations, Inc.
Published: 2014-04-14
License: https://open.fda.gov/license/

Roche Diagnostics GmbH / initiated 2014-04-14 / Terminated / root cause: design

FDA source

Roche Diagnostics Operations, Inc. began a recall of ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count retail strip; 51 count... on 2014-04-14. FDA classified it as Class II and gives the reason as "Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneously low blood glucose readings in patients undergoing Ceftriaxone therapy. The interference is not described in the product...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1616-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-14
Posted: 2014-05-13
Terminated: 2014-09-18
Recalling firm: Roche Diagnostics GmbH
Product: ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact Plus Meters; 17 count sample strip 51 count retail strip; 102 count retail strip; 51 count MedBen strip 51 count Mail Order strip; Sample Kit 16 per case. The ACCU-CHEK Compact Plus Test Strips are for use with the ACCU-CHEK Compact Plus Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips or palm.
Product code: NBW System, Test, Blood Glucose, Over The Counter
Reason for recall: Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneously low blood glucose readings in patients undergoing Ceftriaxone therapy. The interference is not described in the product labeling.
Root cause tag: design
FDA root cause: Device Design
Action: On 4/14/14, Roche Diagnostics Operations issued URGENT MEDICAL DEVICE CORRECTION notification to consignees which included description of the affected product and issue, clinical significance, and actions required. Consignees are directed to call the ACCU-CHEK Customer Care Service Center at 1-800-858-8072 for any questions about the information contained in the notification.
Quantity in commerce: 590,136 boxes
Distribution: Nationwide Distribution.
Product codes and lots: 5599423160, 5599415160, 5919967160, 5919959160, 5919983160, 5907675001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1616-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1616-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-21	2014-05-13

Product code NBW

K113614Class IIAccu-Check Compact Plus Blood Glucose Monitoring SystemRoche Diagnostics / cleared 2013-02-12

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)