Z-1178-2013Class II

The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807

Name: Z-1178-2013 The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807
Creator: Alere San Diego, Inc.
Published: 2013-03-06
License: https://open.fda.gov/license/

Alere San Diego, Inc. / initiated 2013-03-06 / Terminated / root cause: manufacturing process

FDA source

Alere San Diego, Inc. began a recall of The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of... on 2013-03-06. FDA classified it as Class II and gives the reason as "The Alere Cholestech LDX hsCRP cassette (PN 12-807) may have increased imprecision relative to the performance data in the package insert, which may cause differences in quantitative results for hsCRP compared to a...". 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-1178-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-06
Posted: 2013-04-25
Terminated: 2014-03-12
Recalling firm: Alere San Diego, Inc.
Product: The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product Usage: Immunoassay for the determination of C-Reactive Protein (CRP). The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum.
Product code: DCK C-Reactive Protein, Antigen, Antiserum, And Control
Reason for recall: The Alere Cholestech LDX hsCRP cassette (PN 12-807) may have increased imprecision relative to the performance data in the package insert, which may cause differences in quantitative results for hsCRP compared to a reference method or repeat testing on the same patient sample.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Alere sent an Urgent Medical Device Recall letter dated March 6, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to block all stock of the affected lot in their warehouses; discontinue use and discard all stock on hand, complete the provided Customer Verification form to document disposal, contact their primary consignees and advise them of the required discontinuation and disposal of the affected lot. For question call 877-308-8289.
Quantity in commerce: 2333 kits
Distribution: USA Nationwide Distribution
Product codes and lots: Model Number 12-807. ¿ Lot/Unit Codes: 274632, 281847 ¿ Expiration date, or Expected shelf life: 5/5/13, 6/30/13

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1178-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1178-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-01	2013-04-25

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)