Pregnancy Test Control Set Recalled for Temperature Excursion Risk
McKesson recalls Abbott Rapid Dx pregnancy test control sets due to a refrigerator temperature excursion that could cause inaccurate or delayed test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for a medical device control set due to temperature excursion that could affect test accuracy. While this is a risk-of-harm product, the source reports no actual test failures, patient injuries, or illnesses, limiting severity to 'High' per the rubric.
Plain-English summary
Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Sets distributed by McKesson Medical-Surgical Inc. are being recalled. On January 8, 2024, a mechanical failure in a walk-in refrigerator caused facility temperatures to fall below the validated storage range of 35.6-46.4°F (2-8°C) for up to 60 minutes.
This temperature excursion could increase the probability that affected control sets will produce incorrect or delayed test results when used to validate pregnancy (hCG) tests in healthcare settings and laboratories.
Lot KN00589 was distributed nationwide in Arizona, Pennsylvania, and Texas. The recalled product is the Abbott Rapid Dx Reproductive Endocrinology Control Set with positive and negative level controls.
The recalled product
- Product
- Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- test-inaccuracy
- temperature-excursion
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalogue Number: 5011
- UDI/DI: 612479202788
- Lot No. KN00589
Distribution
Distributed nationwide across the United States.
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