FDA Device recall Z-1262-2020
i-STAT CHEM8+ cartridges (blue), List No. 09P31-25
- FDA Device
- Class II
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class II recall of i-STAT CHEM8+ cartridges (blue), List No. 09P31-25 by Abbott Point, citing the I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA recognizes two types of laboratory tests: waived and non-waived. Different….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1262-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-15 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Abbott Point |
| Distribution | US |
Product
i-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge may be used for the quantitative measurement of sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine, and hematocrit in venous, arterial or capillary whole blood.
Reason
The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA recognizes two types of laboratory tests: waived and non-waived. Different CLIA standards apply to waived and non-waived tests as well as the facilities that perform these types of tests. The i-STAT CHEM8+ cartridge contains nine measured assays (sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine and hematocrit) and is categorized as a CLIA waived test for venous whole blood samples, meaning this cartridge could be used in a facility with a CLIA Certificate of Waiver as a waived test.
Identifiers
| code_info | All lots are affected |
|---|
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-1262-2020%22
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