McKesson Medical-Surgical Inc. has recalled 32 units of various medical diagnostic control kits and indicators, including Sekisui Bacterial Vaginosis kits, Abbott Pregnancy (hCG) testing sets, and i-STAT controls. These products were stored in a walk-in refrigerator that experienced mechanical failure on January 8, 2024, causing temperatures to drop below the required range of 35.6°F to 46.4°F for up to 60 minutes. Because these products are used to verify the accuracy of medical tests, this temperature excursion could cause the tests to provide incorrect results or cause significant delays in patient testing. This recall affects specific lots distributed to healthcare facilities in Arizona, Pennsylvania, and Texas.
Use of these compromised controls may result in inaccurate medical test results, which could lead to incorrect patient diagnoses or delayed clinical decisions. Exposure to temperatures outside the validated storage range can degrade the chemical components of the controls, making them unreliable for their intended diagnostic purpose.
Manufacturer instructions for diagnostic devices
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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