Abbott Rapid Dx N America LLC Reproductive recall
Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4…
Why was Abbott Rapid Dx N America LLC Reproductive recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalogue Number: 5011; UDI/DI: 612479202788; Lot No. KN00589;
- Product
- Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pregnancy (hCG) Testing Positive Level / Negative Level 2 X 4…
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Quantity
- 3 units
- Distribution
- US Nationwide distribution in the states of AZ, PA and TX.
- Recall date
- March 27, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)