FDA-Device2024-03-27Class II
Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL
Mckesson Medical-Surgical Inc. Corporate Office
Hazard
Facility Critical Temperature Excursions on 08-JAN 2024 in Walk-In refrigerator due to mechanical failures, causing temperatures to fall below the validated range of 35.6 - 46.4 Degrees Fahrenheit (2 - 8 Degrees Celsius) for up to 60 minutes which could increase the probability of an incorrect test result or a delayed test result.
Sold states
US Nationwide distribution in the states of AZ, PA and TX.
Affected count
2 units
Manufactured in
9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, United States
Products
Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1315-2024Don't want to check this manually?
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