ACCU-CHEK Compact Plus Test Strips For use with: ACCU-CHEK Compact… — Class II medical device recall Z-1616-2014
Terminated recall by Roche Diagnostics Operations, Inc., reported 2014-05-21, distributed nationwide. Roche Diabetes Care has become aware the ACCU-CHEK Compact Plus test strips may produce erroneously low blood
| Recall number | Z-1616-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Operations, Inc., Indianapolis, IN, United States |
| Recall initiated | 2014-04-14 |
| Classified | 2014-05-13 |
| Reported by FDA | 2014-05-21 |
| Terminated | 2014-09-18 |
| Distributed | Nationwide (US) |
| Quantity | 590,136 boxes |
| Reason classes | labeling |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1616-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.