HemoCue Glucose Analyzer Microcuvettes Recalled Due to Cold Chain Failure
Cold chain failures during transit may have compromised HemoCue glucose analyzer microcuvettes, potentially causing incorrect or delayed test results. Affected units were distributed nationwide to healthcare facilities.
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 medical device recall with no reported illnesses or injuries documented in the source. The hazard—storage condition failure during transit—is confirmed but the risk of incorrect test results is theoretical. Per the rubric, risk-of-harm medical devices with no confirmed adverse events score as High (3).
Plain-English summary
HemoCue F/Glucose 201 Analyzer microcuvettes were subject to transit delays during severe thunderstorms, which may have caused products to be stored outside their recommended labeled storage conditions. This storage condition failure could increase the probability of incorrect or delayed test results from the analyzer.
Affected units were distributed nationwide through Mckesson Medical-Surgical Inc. to healthcare facilities in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia. The recalled microcuvettes are identified by Catalog No. 110706 and GTIN 17311091107067.
The potential consequences of exposure to improper storage conditions are compromised product performance, specifically the possibility of incorrect glucose measurements or delayed test results.
The recalled product
- Product
- HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Hazard
- temperature-exposure
- test-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. 110706
- GTIN: 17311091107067
- Order No. 46085136.
Distribution
Distributed nationwide across the United States.
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