HemoCue HemoTrol High Control Product Recalled Due to Storage Conditions
HemoCue Inc HemoTrol High Level 3 control product (Catalog No. 171003002) is being recalled because transit delays and severe thunderstorms may have caused it to be stored outside recommended temperature ranges, potentially resulting in incorrect or delayed test results.
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: The FDA classified this as a Class II recall. The hazard is theoretical (potential for incorrect or delayed test results) with no reported illnesses or injuries stated in the source text, warranting a Moderate severity level.
Plain-English summary
HemoCue Inc HemoTrol High 2x1mL Level 3 control product is being recalled due to storage condition failures during transit. Severe thunderstorms caused delays that may have resulted in the product being stored outside its labeled recommended storage conditions.
This failure could increase the probability of an incorrect test result or a delayed test result. The affected product has Catalog No. 171003002, GTIN 8718734960348, and Order No. 46085136.
The product was distributed nationwide in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. Users of this product should contact their healthcare provider or the manufacturer, McKesson Medical-Surgical Inc. Corporate Office, for guidance on affected units and appropriate next steps.
The recalled product
- Product
- HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- improper-storage
- test-result-error
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. 171003002
- GTIN: 8718734960348
- Order No. 46085136.
Distribution
Distributed nationwide across the United States.
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