FDA Device recall Z-0880-2021
Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and…
- FDA Device
- Class II
- terminated
- Published 2021-01-27
On 2021-01-27 the FDA classified a Class II recall of Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and… by Abbott Point, citing ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in e….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0880-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-12-22 |
| Published | 2021-01-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Abbott Point |
| Distribution | US |
Product
Abbott i-STAT CG8+ cartridges - IVD Intended for quantitative measurement of sodium, potassium, ionized calcium, glucose, pH, pCO2, pO2 and hematocrit in venous, arterial or capillary whole blood List Number: 03P88-25
Reason
Ionized calcium test on some i-STAT CG8+ and EG7+ cartridges may exhibit higher than expected reported results when stored at room temperature (18 to 30C) for periods of time in excess of 3 days for lot numbers *20100 to *20339 and 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y.
Identifiers
| code_info | Stored at room temperature (18 to 30¿C) for periods of time in excess of: 3 days for lot numbers *20100 to *20339 7 d…Stored at room temperature (18 to 30¿C) for periods of time in excess of: 3 days for lot numbers *20100 to *20339 7 days for lot numbers *20340 and above Where * = lot letter A, K, L, M, N, W or Y Primary GTIN (01) 00054749000163) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0880-2021%22
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