Alere San Diego, Inc.: Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Assayed quality control material for use with the Alere Cholestech LDX System.

Recall number

Z-0746-2013

Recalling firm

Alere San Diego, Inc.

Product

Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769 Alere Cholestech LDX Multianalyte Control (hereafter referred to as Controls) enables users to monitor the performance of total cholesterol (TC), high density lipoprotein cholesterol (HDL), triglycerides (TRG), glucose (GLU), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) test procedures on the Alere Cholestech LDX System. The results obtained for the controls are to be compared with the assigned values given on the Expected Values Card, accompanying the package insert, to determine if the procedure is within control limits. Assayed quality control material for use with the Alere Cholestech LDX System.

Status

Terminated

Initiated

2012-10-22

Posted

2013-01-29

Terminated

2013-09-26

Reason

Out of range (increased) HDL Cholesterol results.

Root cause

Component design/selection

Action

A recall letter was sent on 10/22/12 to all customers who purchased the Alere Cholestech LDX Mutianalyte Control, 2 vial set, Catalog Number 88769, Lot #C2510 & Lot #C2510A. The letter informed the customers that these lots of controls may yield results which are out of range high for the Level 2 control when tested with the Alere Cholestech LDX HDL test. Customers are instructed of the actions to be taken. On 11/16/12, the recall expanded to include the Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog 88770, Lot#271097. The problem identified is that these lots of calibration verification materials may yield results which are out of range high when tested with the Alere Cholestech LDX HDL test. Customers are instruted of the actions to be taken. On 3/6/13, the recall expanded to include the Alere Cholestech LDX Calibration Verification, 4 Vial set, Catalog # 88770, Lot#298148 and 301886. The recall expanded to include the Alere Cholestech LDX Multianalyte Control, 2 vial Set, Catalog # 88769, Lots#C2572, C2572A, C2593 and C2593A. Customers are instructed to complete and fax the enclosed verification form within 10 days. Customers with questions are instructed to contact Alere San Diego, 9975 Summers Ridge Rd, San Diego, CA 92121, (877) 308-8289, fax (858) 805-8457, and responses.ts@alere.com.

Quantity

11,166 kits

Distribution

Worldwide Distribution - USA (nationwide) Puerto Rico and South Korea.

Lot, serial or model codes

Lot#C2510, C2510A, C2572, C2572A, C2593, and C2593A.

510(k) numbers

["K102700"]

PMA numbers

not on file

Product code

JJY

Firm FEI

1000125596

Firm city

San Diego

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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