Device recall: The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807. Product…

Class II FDA enforcement event 64701. Recall start date: 6 Mar 2013. Status in the FDA record: Terminated. Termination date: 12 Mar 2014.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Alere San Diego, Inc. started this device recall on 6 Mar 2013. The firm address in the FDA record is in San Diego, CA. FDA put the recall in Class II. FDA event 64701 has 1 product record. The first FDA enforcement report date is 1 May 2013. The record gives the status Terminated, with the termination date 12 Mar 2014.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

USA Nationwide Distribution

Recalling firm

Alere San Diego, Inc., San Diego, CA.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 64701: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1178-2013	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…	2333 kits	Class II	Terminated	1 May 2013

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2013: 1,236
Share of these events in Class II: 90%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 28

Other events of the firm

Other FDA enforcement events of Alere San Diego, Inc.
Initiated	Product (first record)	Type	Class	Records
1 Mar 2024	Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170	Device	Class II	1
24 Jun 2022	The Cholestech LDX System combines enzymatic methodology and solidphase technology to measure total cholesterol, HDL cho	Device	Class II	1
15 Feb 2019	Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d and 1843d -	Device	Class II	1
14 Nov 2017	Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle	Device	Class II	1
12 Oct 2016	Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage Total Controls 5 are qualit	Device	Class II	1
2 Aug 2016	LDX Optical Check Cassettes (OCC) Model Number: 10-228 and 14-535 Cassette in box with foam insert. The cassette is used	Device	Class III	1
11 Jul 2016	Alere INRatio PT/INR System Professional Model Numbers: 0100004 Product Usage: Alere INRatio 2 PT/INR Monitoring System	Device	Class I	9
22 Jun 2016	Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test Device a simp	Device	Class III	7
27 Aug 2015	Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773. Enables users to monitor the performance of total choles	Device	Class III	1
5 Dec 2014	Alere INRatio PT/INR Test Strips, Alere INRatio PT/INR System Professional - 0100071 Alere INRatio PT/INR Test Strips, B	Device	Class I	3

Alere San Diego, Inc.: all 28 events

Official channels

FDA enforcement report Z-1178-2013The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 64701. https://recallregister.com/fda/ii/64701/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: USA Nationwide Distribution
What quantity of product is in FDA event 64701?: The FDA record gives this quantity: 2333 kits
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2013 have the same class?: 90% of the 1,236 device events that started in 2013 are in Class II.