HemoCue Inc Hemotrol Low Control affected by cold chain transit delays
HemoCue Inc Hemotrol Low Level 1 control product was subject to transit delays during severe thunderstorms that may have caused storage outside recommended temperature conditions, potentially leading to 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: This is an FDA Class II recall involving a medical device control product with a risk of incorrect or delayed test results due to storage condition failure. No actual injuries or illnesses have been reported; the hazard is potential and related to product performance rather than direct patient harm.
Plain-English summary
HemoCue Inc is recalling Hemotrol Low 2x1mL Level 1 HemCue Control (Catalog No. 171001002; GTIN: 8718734960300) distributed nationwide in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
The product was subject to transit delays of certain cold chain products due to severe thunderstorms, which may have caused the products to be stored outside the recommended labeled storage conditions. This failure to maintain proper storage temperature could increase the probability of an incorrect test result or a delayed test result.
Customers who have received affected units should contact Mckesson Medical-Surgical Inc. Corporate Office for further guidance on product disposition and return procedures.
The recalled product
- Product
- HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- storage-condition-failure
- incorrect-test-result
- delayed-test-result
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. 171001002
- GTIN: 8718734960300
- Order No. 46085136.
Distribution
Distributed nationwide across the United States.
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