Glucose Control Kit Recalled Due to Improper Storage During Transit
HemoCue glucose control kits may have been exposed to improper storage temperatures during transit due to severe thunderstorms, which could result in inaccurate test results. Affected units were distributed nationwide in 10 states.
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 an FDA Class II recall with no reported illnesses, hospitalizations, or confirmed product failures. The hazard is theoretical—potential for inaccurate test results due to storage temperature deviation. Per the rubric, precautionary recalls with theoretical risks and no reported harm score 2 (Moderate).
Plain-English summary
HemoCue glucose control kits (Catalog No. 180.013.002) manufactured by Mckesson Medical-Surgical Inc. are being recalled due to potential exposure to improper storage temperatures during transit. Severe thunderstorms caused certain units to be stored outside the recommended labeled storage conditions.
This storage deviation could increase the probability of inaccurate test results or delayed test results when the kits are used for quality control testing in laboratories.
The affected products were distributed nationwide in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
Healthcare providers and laboratories that received affected units should contact the manufacturer or their supplier for guidance regarding testing integrity and product replacement options.
The recalled product
- Product
- HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-excursion
- test-result-inaccuracy
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
Distributed nationwide across the United States.
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