FDA Enforcement
Class II
Ongoing
Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
Recall: Z-1312-2024
·
Reported March 27, 2024
Enforcement
- Recall Number
- Z-1312-2024
- Event ID
- 94024
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- March 27, 2024
- Initiation Date
- January 9, 2024
- Classification Date
- March 19, 2024
- Address
- 9954 Maryland Drive, Deep Run Iii Ste. 4000, Richmond, VA, 23233, United States
Description
Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4 mL
Reason
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.
Code Info
Catalogue Number: 5011; UDI/DI: 612479202788; Lot No. KN00589;
Distribution
US Nationwide distribution in the states of AZ, PA and TX.
Quantity
3 units