Alere San Diego, Inc.
San Diego, CA
This page shows every FDA and USDA recall linked to Alere San Diego, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
49
Total Recalls
2009
First Recall
2024
Most Recent
Abbott Cholestech LDX Battery Kit, Model: 3LP656194-PCM-LD, PN: 55170
Apr 30, 2024
· Device
Open, Classified
The Cholestech LDX System combines enzymatic methodology and solidphase
technology to measure total cholestero...
Jun 24, 2022
· Device
Open, Classified
Alere Cholestech LDX Analyzer, model # 14-874 containing power supplies with the identifying codes of 1837d an...
Feb 15, 2019
· Device
Terminated
Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices...
Nov 14, 2017
· Device
Completed
Alere Triage Total 5 Control Level 1, Model No. 88753
Description of the product: The Triage Total Controls 5...
Nov 16, 2016
· Device
Terminated
Alere INRatio2 PT/INR Home Monitoring System
Model Number: 0200432, 0200433
Product Usage:
Alere INRatio 2 PT...
Aug 19, 2016
· Device
Terminated
Alere INRatio PT/INR System Professional
Model Numbers: 0100004
Product Usage:
Alere INRatio 2 PT/INR Monito...
Aug 19, 2016
· Device
Terminated
INRatio Prothrombin Time (PT) Monitoring System
Model Number: 0100007
Product Usage:
The INRatio Prothrombin...
Aug 19, 2016
· Device
Terminated
Alere INRatio PT/INR Test Strips
Model Number: 0100071, 0100139
Product Usage:
The INRatio/INRatio2 Test Stri...
Aug 19, 2016
· Device
Terminated
Alere INRatio Replacement Monitor
Model Number: 0100137
Usage:
The INRatio 2 PT Monitoring system is used fo...
Aug 19, 2016
· Device
Terminated
Alere INRatio2 PT/INR Professional Testing System
Model Number: 0200431
Product Usage:
The INRatio 2 PT Monit...
Aug 19, 2016
· Device
Terminated
Alere INRatio2 PT/INR Professional Monitoring System
Model Number: 55128A
Product Usage:
The Alere INRatio/IN...
Aug 19, 2016
· Device
Terminated
Alere INRatio/ INRatio2 PT/INR Test Strips
Model Number: 99007EU, 99007G1, 99007G3, 99007G5, 99007G7, 99008EU,...
Aug 19, 2016
· Device
Terminated
Alere INRatio2 Replacement Monitor (Home)
Model Number: 0200457
Product Usage:
Alere INRatio 2 PT/INR Home Mo...
Aug 19, 2016
· Device
Terminated
LDX Optical Check Cassettes (OCC)
Model Number: 10-228 and 14-535
Cassette in box with foam insert. The casse...
Aug 2, 2016
· Device
Terminated
Proadvantage Mono Rapid Test Cassette, Catalog No. P080016
a simple test that utilizes an extract of bovine e...
Jun 22, 2016
· Device
Terminated
Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401
a simple test that utilizes an extract of bovi...
Jun 22, 2016
· Device
Terminated
Cardinal Health Mono Rapid Test, Catalog No. B1077-28,
a simple test that utilizes an extract of bovine eryth...
Jun 22, 2016
· Device
Terminated
Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L
a simple test that utilizes an extract of b...
Jun 22, 2016
· Device
Terminated
Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25
a simple test that utilizes an extract of bov...
Jun 22, 2016
· Device
Terminated
Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an extract of...
Jun 22, 2016
· Device
Terminated
Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rapid Test De...
Jun 22, 2016
· Device
Terminated
Alere Cholestech LDX Multianalyte Controls, PN 88769 and 88773.
Enables users to monitor the performance of...
Oct 15, 2015
· Device
Terminated
INRatio Monitors
- 0100004 Alere INRatio PT/INR System Professional
- 0100007 INRatio Prothrombin Time (PT) Mo...
Jan 3, 2015
· Device
Terminated
INRatio 2 Monitors
- 0200431 Alere INRatio 2 PT/INR Professional Testing System
- 0200432 Alere INRatio 2 PT/I...
Jan 3, 2015
· Device
Terminated
Alere INRatio PT/INR Test Strips, Alere INRatio
PT/INR System Professional
- 0100071 Alere INRatio PT/INR Test...
Jan 3, 2015
· Device
Terminated
Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202
Th...
Jun 26, 2014
· Device
Terminated
Alere Triage D-Dimer Test
PN 98100, Lot W53884B.
The Alere Triage D-Dimer Test is a fluorescence immunoassay t...
Jun 6, 2014
· Device
Terminated
Alere INRatio2 PT/INR Professional Test Strips, Model Number: 99008G2. The Alere INRatio2 PT/INR Monitoring Sy...
May 8, 2014
· Device
Terminated
Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Nu...
May 2, 2014
· Device
Terminated
Product Brand Name(s): Alere Triage TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B.
25 i...
Mar 17, 2014
· Device
Terminated
Product Brand Name(s):
Innovacon Oral Fluid Drug Screen Device,
OrALert Oral Fluid Drug Screen Device,
OrAL...
Jan 9, 2014
· Device
Terminated
Product Brand Name(s): Alere Cholestech LDX Lipid Profile"GLU Test Cassette, Model 10-991.
Product Generic Nam...
Nov 22, 2013
· Device
Terminated
Alere Triage TOX Drug Screen Control 1
Product Generic Name: Quality Control Material
Description of the pro...
Oct 23, 2013
· Device
Terminated
Alere" hCG Combo Cassette (20/10 mIU/mL) Kit.
Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a...
May 25, 2013
· Device
Terminated
Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026)
The SP hCG Cassette Rapid...
May 21, 2013
· Device
Terminated
The Alere Cholestech LDX high sensitivity C-Reactive Protein (hsCRP) Test Cassette, Model Number 12-807.
Pr...
Apr 25, 2013
· Device
Terminated
IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201
The MONO test (Wh...
Apr 18, 2013
· Device
Terminated
Alere Cholestech LDX ALT AST Test Cassette, Model #12-788.
For the in vitro quantitative determination of ala...
Apr 17, 2013
· Device
Terminated
Alere Cholestech LDX Multianalyte Control, 2 vial set, Catalog Number: 88769
Alere Cholestech LDX Multianalyt...
Jan 29, 2013
· Device
Terminated
Alere Cholestech LDX Calibration Verification, 4 vial set, Catalog Number: 88770
Alere Cholestech LDX Calibra...
Jan 29, 2013
· Device
Terminated
Triage TOX Drug Screen Panel, Model# 94400.
Product Usage:
The Triage TOX Drug Screen is a fluorescence imm...
Oct 10, 2012
· Device
Terminated
Alere Triage TOX Drug Screen 9 Panel, P/N: 94402.
The Alere Triage TOX Drug Screen is a fluorescence immunoas...
Sep 26, 2012
· Device
Terminated
Alere Triage Tox+MTD Drug Screen, PN 94400
Product Usage:
The Alere Triage TOX Drug Screen is a fluorescence...
Jul 19, 2012
· Device
Terminated
Alere Triage CardioProfiler Panel PN 97100CP
Used for the quantitative determination of creatine kinase MB, m...
Jul 6, 2012
· Device
Terminated
Alere Triage Profiler SOB Panel PN 97300
Used for the determination of creatine kinase MB, myoglobin, troponi...
Jul 6, 2012
· Device
Terminated
Triage D-dimer PN 98100
Used as an aid in the assessment and evaluation of patients suspected of having disse...
Jul 6, 2012
· Device
Terminated
Alere Triage BNP PN 98000XR
Intended to be used as an aid in the diagnosis and assessment of severity of cong...
Jul 6, 2012
· Device
Terminated
Alere Triage Cardiac Panel PN 97000HS
Used for the quantitative determination of creatine kinase MD (CK--MB),...
Jul 6, 2012
· Device
Terminated