Z-1508-2022Class II

The Cholestech LDX System combines enzymatic methodology and solidphase technology to measure total...

Name: Z-1508-2022 The Cholestech LDX System combines enzymatic methodology and solidphase technology to measure total...
Creator: Alere San Diego, Inc.
Published: 2022-06-24
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2022-06-24 / Open, Classified / root cause: design

FDA source

Alere San Diego, Inc. began a recall of The Cholestech LDX System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cholesterol, triglycerides and glucose... on 2022-06-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1508-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-06-24
Posted: 2022-08-06
Recalling firm: Alere San Diego, Inc.
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
Product code: CGA Glucose Oxidase, Glucose
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).
Root cause tag: design
FDA root cause: 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
Product codes and lots: All lots of Part/UDI-DI: 10-991/00893038002654, 99021/00899722002344, 14-531/04571226470831, 10-990/00893038002647, 10-989/00893038002630, 10-987/00893038002616

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1508-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1508-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-17	2022-08-06

Product code CGA

K120615Class IIAlere Cholestech Ldx Analyzer, Alere Cholestech Ldx Lipid Profile - Glu CassetteAlere San Diego Inc. Dba Biosite,Innovacon,Hemosen / cleared 2013-05-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)