Recall Z-1262-2020— 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 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..

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.