Abbott Point Of Care Inc.: Medical Device Recall in 2020 - (Recall #: Z-1262-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 15, 2020

Date Posted: February 26, 2020

Recall Number: Z-1262-2020

Event ID: 84728

Reason for Recall:

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.

Status: Terminated

Product Quantity: 9,049,725

Code Information:

All lots are affected

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated