Z-2460-2008

Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic test that measures...

Name: Z-2460-2008 Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic test that measures...
Creator: Cholestech Corp
Published: 2006-08-03
License: https://open.fda.gov/license/

Cholestech Corp. / initiated 2006-08-03 / Terminated / root cause: manufacturing process

FDA source

Cholestech Corp began a recall of Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic test that measures hemoglobin A1c (HbA1c) on 2006-08-03. The reason FDA records is "Cholestech Corp. was notified by the foreign manufacturer of the A1C test cartridge that stability data indicated that the product would not meet performance claims through the end of its shelf life". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2460-2008
Status: Terminated
Initiated: 2006-08-03
Posted: 2008-09-23
Terminated: 2009-10-07
Recalling firm: Cholestech Corp.
Product: Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is an in-vitro diagnostic test that measures hemoglobin A1c (HbA1c).
Product code: LCP Assay, Glycosylated Hemoglobin
Reason for recall: Cholestech Corp. was notified by the foreign manufacturer of the A1C test cartridge that stability data indicated that the product would not meet performance claims through the end of its shelf life.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A customer notification letter was sent to Cholestech consignees who had received product from this lot. The letter dated 8/3/2006 instructed customers to discontinue use of the lot of product, destroy product according to in-house standard procedures and contact Cholestech Technical Services for replacement. It also instructed to provide a copy of the letter to other users if the lot of product was further distributed. A response form was included with instructions to complete and return. Contact Cholestech Corp at 1-510-781-3505 for assistance.
Quantity in commerce: 9,324 Cartridges
Distribution: U.S. state of Colorado. OUS: India, Slovenia, Germany, Tunisia, Taiwan, Canada, Philippines, South Africa and Mexico
Product codes and lots: Catalog #12-658, Lot #066T28

Product code LCP

K041635Class IIG5 I Hba1c Test, G5 II Hba1c TestProvalis Diagnostics , Ltd. / cleared 2004-08-16

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)