FDA-Device2013-05-01Class II
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.
Alere San Diego, Inc.
Hazard
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.
Sold states
USA Nationwide Distribution
Affected count
2333 kits
Manufactured in
9975 Summers Ridge Rd, San Diego, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1178-2013Don't want to check this manually?
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