Medical Device Recall: Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
Mckesson Medical-Surgical Inc. Corporate Office · January 9, 2024
Reason for Recall
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.
Distribution
US Nationwide distribution in the states of AZ, PA and TX.
States Affected
NATIONWIDE
Quantity Affected
3 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1312-2024
Status: ongoing
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