Contour Next Control Solution for Contour Next Blood Glucose Test… — Class II medical device recall Z-2482-2015
Terminated recall by Bayer Healthcare, LLC, reported 2015-09-09. If the control solution bottle is not thoroughly shaken prior to use, the control test result may be higher th
| Recall number | Z-2482-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bayer Healthcare, LLC, Mishawaka, IN, United States |
| Recall initiated | 2015-06-22 |
| Classified | 2015-08-28 |
| Reported by FDA | 2015-09-09 |
| Terminated | 2016-05-23 |
| Countries outside the US | AT, AU, BE, BG, CA, CH, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IT, KR, LT, LU, LV, NL, NO, PH, PT, RO, RS, SE, SI, SK, TH |
| Quantity | 5 million |
Product
Contour Next Control Solution for Contour Next Blood Glucose Test System. Liquid quality control solution. Plastic bottle, 2.5mL. Indicated for use with fresh fingertip capillary whole blood samples.
Reason for recall
If the control solution bottle is not thoroughly shaken prior to use, the control test result may be higher than the control range and may not be recognized and marked as a control test by the blood glucose meter. Also, the control solution, used as a quality control test in blood glucose meter systems, may read outside the specified range too high or too low.
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-2482-2015. 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.