Reported Mar 27, 2024 · Ongoing
Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL
Mckesson Medical-Surgical Inc. Corporate Office
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mckesson Medical-Surgical Inc. Corporate Office · 9954 Maryland Drive · Richmond, VA · 23233
Is this the product you have?
- Abbott Point of Care Control Control i-STAT¿ Level 1 10 X 1.7 mL
- Lot codes and dates
- Catalogue Number06F1201
- UDI/DI54749000463
- Lot No101164
- Amount recalled
- 1 unit
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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