HemoCue Glucose Control Kit Affected by Improper Storage During Transit
HemoCue Glucose Aqueous Control Kit units may have been stored outside recommended conditions due to transit delays during severe thunderstorms, potentially affecting test result accuracy.
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 recall with no reported illnesses or injuries. The hazard is a potential for incorrect or delayed test results due to storage excursion during transit, which represents a theoretical risk rather than confirmed harm. The source text explicitly describes a failure mode without any documented adverse outcomes.
Plain-English summary
HemoCue Inc Glucose Aqueous 1 HI/LO Control Kit (Catalog No. 180.013.002) distributed nationwide is being recalled because certain units may have experienced improper storage conditions during transit.
Severe thunderstorms caused transit delays that resulted in some cold chain products being stored outside the manufacturer's recommended labeled storage conditions. This storage failure could increase the probability of an incorrect test result or a delayed test result.
The product was distributed nationwide in the following states: Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. The recalling firm is Mckesson Medical-Surgical Inc. Corporate Office.
Customers in affected states who have received this product should contact the manufacturer or their distributor to determine whether their units may have been affected and whether they should be replaced.
The recalled product
- Product
- HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 1
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)
- Catalog No. 180.013.002
- GTIN: 8718734960935
- Order No. 46096008.
Distribution
Part of a larger recall action
This product is one of 32 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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