Alere Cholestech LDX Analyzer Recalled for Reversed Power Supply Polarity
Alere San Diego, Inc. is recalling 186 Alere Cholestech LDX Analyzer kits because the power supplies have reversed polarity, rendering the devices inoperable.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The defect renders the device inoperable, posing no risk of injury or adverse health consequences, which aligns with the criteria for cosmetic defects or documentation issues.
Plain-English summary
Alere San Diego, Inc. is recalling 186 Alere Cholestech LDX Analyzer kits, model # 14-874, that contain power supplies with identifying codes 1837d and 1843d. The recall covers units distributed nationwide in the United States, including Alaska, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington, and Wisconsin. No consignees outside the United States are listed.
The recall is due to a manufacturing defect where the polarity of the output of the power supplies was reversed. This defect renders the power supplies nonfunctional and the analyzer inoperable. The Alere Cholestech LDX System is a small, portable analyzer and test cassette system intended for in vitro diagnostic use only, specifically for the quantitative determination of total cholesterol, HDL cholesterol, triglycerides, and glucose in whole blood.
Affected units can be identified by specific lot codes for meter kits (418197, 418198, 418199, 418252, & 418253) and power supplies (724599, 724604, & 725914), as well as a list of specific serial numbers provided in the recall documentation. Users should check their devices against these codes and serial numbers to determine if they are affected.
The recalled product
- Product
- Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d - Product Usage: The Alere Cholestech LDX System is a small, portable analyzer and test cassette system. The System is for in vitro diagnostic use only. The…
- Manufacturer
- Alere San Diego, Inc.
- Hazard
- Affected units
- 186
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 (20)
- Lot/Unit Codes: Lot codes of Meter Kits: 418197
- 418198
- 418199
- 418252
- & 418253 Lot codes of Power Supplies: 724599
- 724604
- & 725914 Serial Numbers: AA184455
- AA184344
- AA184328
- AA184388
- AA184304
- AA184349
- AA184396
- AA184339
- AA184421
- AA184280
- AA184435
- AA184427
- AA184395
- AA183401
Distribution
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