Accu-Chek Aviva Plus Test Strip — Class II medical device recall Z-2185-2018
Terminated recall by Roche Diabetes Care, Inc., reported 2018-06-20, distributed nationwide. The recalling firm identified four US lots of test strips out of specification. Affected strips show increased
| Recall number | Z-2185-2018 |
|---|---|
| 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 |
| Reason classes | specification failure |
| Lot numbers | 496947, 497291, 497296, 497325 |
| Model numbers | 06908217001, 06908268001, 06908349001 |
Product
Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Usage: The Accu-Chek Aviva Plus test strips are for use with the Accu-Chek Aviva Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm, upper arm, or palm.
Reason for recall
The recalling firm identified four US lots of test strips out of specification. Affected strips show increased potential for strip errors prior to applying blood, strips not detected once inserted, or biased results, 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.
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-2185-2018. 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.