i-STAT DE handheld data processing module for clinical use — Class II medical device recall Z-0926-2018
Terminated recall by Abbott Point Of Care Inc., reported 2018-03-14, distributed in AK, AL, AR, AZ, CA, CO, CT, DC…. Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lists will not u
| Recall number | Z-0926-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Abbott Point Of Care Inc., Princeton, NJ, United States |
| Recall initiated | 2017-09-12 |
| Classified | 2018-03-08 |
| Reported by FDA | 2018-03-14 |
| Terminated | 2018-08-23 |
| Distributed | AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY |
| Countries outside the US | AU, CA, IT, SE |
| Quantity | 894 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00054749001255 |
Product
i-STAT DE handheld data processing module for clinical use, Software Version 2.8, List Number:08K46-01115200 (UDI: 00054749001255)
Reason for recall
Issues resulting from upgrade to software version 2.8: (1) Location, operator, stored patient lists will not update, and (2) Customized Reference Ranges, Action Ranges, and Custom Reportable Ranges are reset to factory default values. No erroneous results are generated as a result of this issue.
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-0926-2018. 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.