Radiometer Medical ApS recalls ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
There is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+.
Read the official notice →- Date
- 2022-07-13
- Country
- United States
- Brand
- Radiometer Medical ApS
- Product
- ABL800 Flex Analyzer Model Numbers 393-800 and 393-801
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of AR, AZ,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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