Cholestech LDX Lipid Profile and Glucose Test Kits Recalled
McKesson Medical-Surgical is recalling Cholestech LDX Lipid Profile+Glucose test kits due to transit delays and severe thunderstorms that may have exposed products to improper storage conditions, risking 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 an FDA Class II medical device recall involving a diagnostic test where improper storage conditions could produce incorrect or delayed results, affecting patient care. Although no illnesses or injuries are reported in the source text, the potential for incorrect test results constitutes a risk of harm to patients relying on accurate diagnostic information.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Cholestech LDX Lipid Profile+Glucose test kits (Catalog No. 97991; GTIN: 893038002937) distributed nationwide in Alabama, Arkansas, Illinois, Kansas, Montana, North Carolina, New Jersey, Oregon, South Carolina, Tennessee, and West Virginia.
The recall was initiated due to transit delays caused by severe thunderstorms. These delays may have caused the products to be stored outside the manufacturer's recommended labeled storage conditions. This storage failure could increase the probability of an incorrect test result or a delayed test result.
Patients and healthcare providers who have these test kits should contact their healthcare provider or the manufacturer with questions about whether their kits may be affected or what steps to take regarding any tests that may have been performed with potentially affected units.
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
- 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. 97991
- GTIN: 893038002937
- Order No. 46102674.
Distribution
Distributed nationwide across the United States.
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