ACCU-CHEK Compact Plus Test Strips recallZ-1616-2014 · Roche Diagnostics Operations, Inc. · initiated Apr 14, 2014
Class II Terminated All recalls posted in May 2014
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Roche Diagnostics Operations, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1616-2014
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Apr 14, 2014
- Posted by the FDA
- May 13, 2014
- Recalling firm
- Roche Diagnostics Operations, Inc.
- Quantity
- 590,136 boxes
- Product code
- NBW
- FDA submissions
- K113614
- Distribution
- Nationwide Distribution.
Product description
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.
Code information (models, lots, serial numbers)
5599423160, 5599415160, 5919967160, 5919959160, 5919983160, 5907675001
Other devices under the same FDA submission
1 device cleared under K113614 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Accu-Chek Compact Plus 05599415160Roche Diabetes Care GmbH · Glucose Dehydrogenase, Glucose10 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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