Recall Z-1178-2013— Alere San Diego, Inc.

Name: FDA recall Z-1178-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-06

Class II · Terminated

Class II FDA medical device recall by Alere San Diego, Inc., initiated 2013-03-06, terminated 2014-03-12. It names one FDA 510(k) clearance: K040579. 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.. Reason: 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..

Recalling firm: Alere San Diego, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-03-06
Terminated: 2014-03-12
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K040579 — CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)Cholestech Corp.·cleared 2004-06-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.