Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770 Alere Cholestech LDX Calibration Verifi

FDA device recall Z-0747-2013 · posted 2013-01-29 · Terminated

Recall details

Recalling firm

Alere San Diego, Inc.

Reason for recall

Out of range (increased) HDL Cholesterol results.

Action taken

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.

Root cause

Component design/selection

Status

Terminated

Product code

JJY

Quantity affected

614 kits

Distribution

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

Date initiated

2012-10-22

Date posted

2013-01-29

Date terminated

2013-09-26

Location

San Diego, CA

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