Alere San Diego

10 FDA 510(k) clearances · Recalling firm

Record	Firm	Date
Alere Triage CardioProfiler Panel, PN 97100CP. The test is used as an aid in the diagnosis recall (Z-1466-2012)	Alere San Diego	2012-04-26
Alere Triage Profiler SOB Panel, PN 97300. The test is used as an aid in the diagnosis of recall (Z-1467-2012)	Alere San Diego	2012-04-26
Product Brand Names: Triage Drugs of Abuse Panel 8 Test Kit (K924476), Triage Drugs of Abu recall (Z-1130-2012)	Alere San Diego	2012-03-01
Strep A Rapid Test Cassette (K031784), IST-502 Cassettes. Brand Name (Catalog Number): Acc recall (Z-1074-2012)	Alere San Diego	2012-02-22
Strep A Twist Rapid Test Cassette (K023766), IST-502T Twist Cassettes. Brand Name (Catalog recall (Z-1075-2012)	Alere San Diego	2012-02-22
Alere Cholestech LDX Analyzer, Model Number: 10-004, 14-874, 14-875, in vitro diagnostic. recall (Z-0964-2012)	Alere San Diego	2012-02-06
Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000 An immunoassay u recall (Z-0521-2012)	Alere San Diego	2012-01-11
PDI Alcohol Prep Pads packaged in the INRatio kit. PDI Alcohol Prep Pads, 100/box. Alcohol recall (Z-0188-2012)	Alere San Diego	2011-11-16
Calloway LabsMulti-Drug 9 Panel Assay A rapid, one step screening test for the simultaneou recall (Z-2881-2011)	Alere San Diego	2011-07-27
0200086, Triad Alcohol Prep Pads, 100 box 0200432, Alcohol Prep Pads, packaged in the Aler recall (Z-2661-2011)	Alere San Diego	2011-06-24

Every clearance here is in the API, with alerts when new ones post.