FDAFDA · Food and drugs·Recall number Z-1312-2024
Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
Published March 27, 2024 · Recall initiated: January 9, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Distributor
- US Nationwide distribution in the states of AZ, PA and TX.
- Lot
- Catalogue Number: 5011; UDI/DI: 612479202788; Lot No. KN00589;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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