i-STAT cTnI cartridge — Class II medical device recall Z-0761-2020
Terminated recall by Abbott Point Of Care Inc., reported 2020-01-08, distributed in AK, AL, AZ, CA, CT, DC, FL, GA…. i-STAT¿ cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed r
| Recall number | Z-0761-2020 |
|---|---|
| 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 | 2019-10-16 |
| Classified | 2019-12-31 |
| Reported by FDA | 2020-01-08 |
| Terminated | 2020-05-04 |
| Distributed | AK, AL, AZ, CA, CT, DC, FL, GA, HI, IL, IN, KS, KY, MD, MI, MS, NC, NE, NH, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, WA, WV, WY |
| Quantity | 3,465,875 |
Product
i-STAT cTnI cartridge
Reason for recall
i-STAT¿ cTnI blue cartridges may generate a higher than expected number of quality check codes. The observed rate of quality check codes could be in the 3 to 5% range.
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-0761-2020. 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.