Z-2457-2008

Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high...

Name: Z-2457-2008 Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high...
Creator: Cholestech Corp
Published: 2006-08-09
License: https://open.fda.gov/license/

Cholestech Corp. / initiated 2006-08-09 / Terminated / root cause: design

FDA source

Cholestech Corp began a recall of Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro... on 2006-08-09. The reason FDA records is "Test results are high, outside of control material upper limit specification. Results could be as high as 15%". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2457-2008
Status: Terminated
Initiated: 2006-08-09
Posted: 2008-09-20
Terminated: 2009-09-30
Recalling firm: Cholestech Corp.
Product: Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum. Measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. The test cassettes are for use with the LDX analyzer.
Product code: DCK C-Reactive Protein, Antigen, Antiserum, And Control
Reason for recall: Test results are high, outside of control material upper limit specification. Results could be as high as 15%.
Root cause tag: design
FDA root cause: Device Design
Action: Cholestech provided its three distributors a notification letter/response form with instructions to distribute the letter to their customers/end users dated August 9, 2006. The letter instructed customers to discontinue use of the lot of cassettes, return remaining cassettes to Cholestech through the Technical Service Representative and to complete and return the response form. The end users returned the signed letters directly to Cholestech so that effectiveness checks could be completed.
Quantity in commerce: 2, 910 cassettes
Distribution: Nationwide Distribution --- including states of Virginia, Texas and North Carolina, Ohio, Arkansas, Washington, Florida , California and Michigan.
Product codes and lots: Catalog #12-807, Lot #C17-6434

Product code DCK

K040579Class IICholetech Ldx High-Sensitivity C-Reactive Protein (Hs-Crp)Cholestech Corp. / cleared 2004-06-18

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)