Hemoglobin Control Material Recalled Due to Transit Storage Temperature Excursion
HEMOCUE Hemotrol High quality control material is being recalled due to transit delays caused by severe thunderstorms that may have resulted in improper storage conditions, potentially affecting test accuracy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a laboratory quality control device. Although no illnesses or injuries have been reported, it qualifies as a risk-of-harm product because storage temperature deviations could lead to incorrect or delayed test results, potentially affecting patient testing decisions.
Plain-English summary
HEMOCUE INC Hemotrol High Level 3 quality control material (Catalog No. 171003002) manufactured by Mckesson Medical-Surgical Inc. is being recalled due to transit delays caused by severe thunderstorms. These delays resulted in the products being stored outside the recommended labeled storage conditions.
This quality control material is used in hemoglobin testing devices. When stored outside the specified temperature range, the material's stability can be compromised, which may increase the probability of producing incorrect or delayed test results.
The affected products were distributed nationwide to laboratories and healthcare facilities in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
Laboratories and healthcare facilities that received this product should contact the manufacturer, Mckesson Medical-Surgical Inc., for guidance on whether their shipment was affected by the transit delays and for instructions on appropriate corrective actions.
The recalled product
- Product
- HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- incorrect-test-result
- delayed-test-result
- temperature-excursion
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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