Abbott i-STAT CHEM8+ Cartridges Recalled for Lack of FDA Clearance
Abbott Point Of Care Inc. is recalling i-STAT CHEM8+ cartridges because they are not FDA cleared and do not have CLIA waived status.
- 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…
- Category
- Medical Device
- Distribution
- Distributed nationwide