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U.S. Department of Health and Human Services

Class 2 Device Recall Cholestech LDX System

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  Class 2 Device Recall Cholestech LDX System see related information
Date Initiated by Firm June 24, 2022
Create Date August 06, 2022
Recall Status1 Open3, Classified
Recall Number Z-1508-2022
Recall Event ID 90508
510(K)Number K120615  
Product Classification Glucose oxidase, glucose - Product Code CGA
Product The Cholestech LDX¿ System combines enzymatic methodology and solidphase
technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose. Samples
used for testing can be whole blood from a fingerstick (collected in a lithium heparin-coated capillary tube) or venipuncture. The sample is applied to an Cholestech LDX¿ cassette.

Description/Part: Cholestech LDX Lipid Profile GLU Cassette/10-991, 99021, 14-531;
Cholestech LDX TC HDL GLU Cassette/10-990;
Cholestech LDX Lipid Profile Cassette/10-989;
Cholestech LDX TC HDL Cassette/10-987
Code Information All lots of Part/UDI-DI: 10-991/00893038002654, 99021/00899722002344, 14-531/04571226470831, 10-990/00893038002647, 10-989/00893038002630, 10-987/00893038002616
Recalling Firm/
Manufacturer		 Alere San Diego, Inc.
9975 Summers Ridge Rd
San Diego CA 92121-2997
For Additional Information Contact
858-805-2000 Ext. 3015
Manufacturer Reason
for Recall		 Cholesterol test cassettes package insert is to be updated with new bilirubin interference information because it was found that samples containing bilirubin, at concentrations greater than 2.0 mg/dL (conjugated) or 1.6 mg/dL (unconjugated), can result in low recovery of Triglyceride (TRG) and High-Density Lipoproteins (HDL).
FDA Determined
Cause 2		 Device Design
Action On 6/24/22, correction notices were mailed and emailed to customers who were asked to take the following actions: 1) Test results from patients with bilirubin levels above 2.0 mg/dL (conjugated) or 1.6 mg/dL (unconjugated) should be verified using another test method. 2) Complete and return the Customer Reply Form. 3) If you have forwarded the products listed above to other laboratories, please inform them of this Product Correction and provide to them a copy of this letter. 4) Retain this letter for your laboratory records. Customers with questions are encouraged to contact Technical Service at 877-308-8289.
Quantity in Commerce 436,990
Distribution US: IL, NV, FL, LA, CA, MA, MN, NC, AK, NE, TX, PA, RI, SC, TN, OK, KY, GA, NY, MO, CO, AZ, OH, HI, VA, KS, IN, AL. OUS: GB, ZA, NO, NL, FI, IE, IQ, IT, CH, DE, ES, HU, SI, NA, PT, IS, NG, PL, CY, TN, BH, ID, MY, AU, SG, JP, IN, BD, KR, HK, BR, CO, AR, CA
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = CGA and Original Applicant = ALERE SAN DIEGO INC. DBA BIOSITE,INNOVACON,HEMOSEN
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