FDA Device recall Z-0761-2020
i-STAT cTnI cartridge
- FDA Device
- Class II
- terminated
- Published 2020-01-08
On 2020-01-08 the FDA classified a Class II recall of i-STAT cTnI cartridge by Abbott Point, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0761-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-16 |
| Published | 2020-01-08 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott Point |
| Distribution | 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 |
Product
i-STAT cTnI cartridge
Reason
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.
Identifiers
| code_info | List Number: 06P23-25 UDI: (01)00054749001986 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0761-2020%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.