Cholestech LDX Lipid and Glucose Test Kits Recalled for Cold Chain Failure
Mckesson is recalling Cholestech LDX Lipid Profile and Glucose test kits due to transit delays from severe thunderstorms that may have caused improper storage. The recall addresses the risk of incorrect or delayed test results.
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 a risk-of-harm medical device where incorrect diagnostic results could impact patient health decisions. Although no illnesses or injuries have been reported and the risk is theoretical rather than confirmed, the hazard of test inaccuracy for a diagnostic device warrants a High severity classification.
Plain-English summary
Mckesson Medical-Surgical Inc. is recalling Cholestech LDX Lipid Profile+Glucose test kits (Catalog No. 97991, GTIN 893038002937). These diagnostic tests are used to measure cholesterol and glucose levels.
The recall is due to transit delays caused by severe thunderstorms that may have resulted in the products being stored outside their recommended labeled storage conditions. This failure could increase the probability of incorrect test results or delayed test results.
The affected products were distributed nationwide to customers in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
The recalled product
- Product
- ABBOTT RAPID DX N AMERICA LLC CHOLESTECH LDX LIPID PROFILE+GLUCOSE (10/BX 50BX/CS) TEST.
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Medical Device — Diagnostic Test
- Hazard
- cold-chain-failure
- 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. 97991
- GTIN: 893038002937
- Order No. 46102674.
Distribution
Distributed nationwide across the United States.
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