FDA Device recall Z-2185-2018
Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Us…
- FDA Device
- Class II
- terminated
- Published 2018-06-20
On 2018-06-20 the FDA classified a Class II recall of Accu-Chek Aviva Plus Test Strip, Blood glucose monitoring system, Catalog nos. 06908217001, 06908268001, 06908349001,06908217001 Product Us… by Roche Diabetes Care, citing 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 detec….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2185-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-05-07 |
| Published | 2018-06-20 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Diabetes Care |
| Distribution | US |
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
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.
Identifiers
| code_info | Lots 496947, 497291, 497296, 497325 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2185-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.