Recall Z-1263-2020— Abbott Point Of Care Inc.

Class II FDA medical device recall by Abbott Point Of Care Inc., initiated 2020-01-15, terminated 2021-03-02. FDA's recall record names no specific 510(k) clearance for this event. Product: i-STAT CG4+ cartridge (blue), List No. 03P85-50. UDI (01) 00054749002269 - Product Usage: The i-STAT CG4+ cartridge is intended for the quantitative measurement of lactate, pH, pCO2, and pO2 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..

Recalling firm

Abbott Point Of Care Inc.

Classification

Class II

Status

Terminated

Initiated

2020-01-15

Terminated

2021-03-02

Firm location

Princeton, NJ, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.