Laboratory Control Material Recalled Due to Temperature Storage Excursion
Abbott Point of Care Control i-STAT Level 3 control material (Lot 121164) is being recalled due to temperature excursions in storage that could affect test accuracy. Affected units were distributed in Arizona, Pennsylvania, and Texas.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II FDA recall involving a laboratory control material. No illnesses, injuries, or hospitalizations have been reported. The hazard is theoretical—improper storage could affect test accuracy—but actual test failures or patient harm have not been documented. This constitutes a precautionary recall with Moderate severity.
Plain-English summary
Abbott Point of Care Control i-STAT Level 3 1.7 mL is a laboratory control material used to verify the accuracy of i-STAT blood analyzers in clinical settings. The recalled lot number is 121164 (Catalogue Number 06F1401), manufactured by McKesson Medical-Surgical Inc.
On January 8, 2024, a facility refrigerator experienced mechanical failures that caused temperatures to fall below the validated storage range of 35.6 to 46.4 degrees Fahrenheit (2 to 8 degrees Celsius) for up to 60 minutes. This temperature excursion could degrade the control material and increase the risk of incorrect or delayed test results.
The affected units were distributed nationwide to facilities in Arizona, Pennsylvania, and Texas. Users of this control material should contact McKesson Medical-Surgical Inc. regarding the recalled lot.
The recalled product
- Product
- Abbott Point of Care Control Control i-STAT¿ Level 3 1.7 mL
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 2
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Catalogue Number: 06F1401
- UDI/DI: 54749000661
- Lot No: 121164
Distribution
Part of a larger recall action
This product is one of 5 recalled by Mckesson Medical-Surgical Inc. Corporate Office under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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