Alere Cholestech LDX Calibration Verification Recall for HDL Errors
Alere San Diego, Inc. is recalling 614 kits of Cholestech LDX Calibration Verification due to out-of-range HDL cholesterol results.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 agency classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Alere San Diego, Inc. is recalling 614 kits of Alere Cholestech LDX Calibration Verification, Catalog Number 88770. The affected lots are 271097, 298148, and 301886. This product is used to monitor the performance of total cholesterol, HDL, triglycerides, and glucose test procedures on the Alere Cholestech LDX System.
The recall was initiated because the product produced out-of-range (increased) HDL Cholesterol results. The agency has classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.
The affected products were distributed worldwide, including the United States (nationwide), Puerto Rico, and South Korea. Users should stop using the affected kits and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verification (hereafter referred to as CAL VERS) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL)…
- Manufacturer
- Alere San Diego, Inc.
- Hazard
- Affected units
- 614
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)
- Lot#271097
- 298148
- and 301886
Distribution
Part of a larger recall action
This product is one of 2 recalled by Alere San Diego, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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