Alere Cholestech LDX Multianalyte Controls, PN 88769 and… recallZ-0122-2016 · Alere San Diego, Inc. · initiated Aug 27, 2015
Class III Terminated All recalls posted in October 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Alere San Diego, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect.
FDA root cause category: Error in labeling
What the company is doing
Customer notification letters dated 8/25/15 and 9/3/15 were sent to customers to inform them that Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect. Customers are informed that the Alere Cholestech LDX Total Cholesterol and Triglyceride assays continue to perform as expected. However, if customers' facility has used the control lot to test Total Cholesterol or Triglycerides as part of their Quality Control program, Alere San Diego recommends that they verify previous results or perform control testing using the replacement Expected Value Card or replacement control materials. The letters also provide customers with actions to be taken. Customers with questions are instructed to contact: Alere San Diego, Inc. 9975 Summers Ridge Road San Diego, CA 92121 U.S.A. Phone: 877-308-8289, FAX: 866-333-9839, E-mail: [email protected].
Recall details
- Recall number
- Z-0122-2016
- Recall class
- Class III
- Status
- Terminated
- Initiated by the company
- Aug 27, 2015
- Posted by the FDA
- Oct 15, 2015
- Recalling firm
- Alere San Diego, Inc.
- Quantity
- 190 kits
- Product code
- JJY
- FDA submissions
- K102700
- Distribution
- Nationwide Distribution.
Product description
Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG) and glucose (GLU) test procedures.
Code information (models, lots, serial numbers)
Lot C3091 and Lot C3091A
Other devices under the same FDA submission
1 device cleared under K102700 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Cholestech LDX™ 88773Alere San Diego, Inc. · Multi-Analyte Controls, All Kinds (Assayed)1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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