Accu-Chek Inform II Test Strip — Class II medical device recall Z-2187-2018
Terminated recall by Roche Diabetes Care, Inc., reported 2018-06-20, distributed nationwide. The recalling firm has identified two lots of test strips that are out of specification. Affected test strips
| Recall number | Z-2187-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diabetes Care, Inc., Indianapolis, IN, United States |
| Recall initiated | 2018-05-07 |
| Classified | 2018-06-14 |
| Reported by FDA | 2018-06-20 |
| Terminated | 2020-01-16 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BB, BE, BG, BH, BR, BS, CA, CH, CL, CN, CO, CR, DE, DK, DO, ES, FI, GB, GH, GR, GT, HK, HN, HU, ID, IE, IL, IN, IT, JM, JO, JP, KE, KR, KW, LB, LT, LU, MT, MX, MY, NL, NO, NZ, OM, PH, PK, PL, PT, RS, SA, SE, SG, SI, SV, TH, TW, VN, ZA |
| Quantity | 295,248 |
| Reason classes | specification failure |
| Lot numbers | 476340 |
| Model numbers | 05942861001 |
Product
Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product Usage: The Accu-Chek Inform II test strips are for use with the Accu-Chek Inform II meter to quantitatively measure glucose (sugar) in venous whole blood, arterial whole blood, neonatal heel stick, or fresh capillary whole blood samples drawn from the fingertips as an aid in monitoring the effectiveness of glucose control. The system is not for use in diagnosis or screening of diabetes mellitus, nor for testing neonate cord blood samples.
Reason for recall
The recalling firm has identified two lots of test strips that are out of specification. Affected test strips show an increased potential for: strip errors prior to applying a blood sample; strips not detected once inserted; or a biased result may occur, which may not be detectable. In the case of a biased result, incorrect action could be taken by the user in response to the displayed blood glucose result as compared to the actual blood glucose value.
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-2187-2018. 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.