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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Product Detail

Product Description The Alere Cholestech LDX® high sensitivity C-Reactive Protein (hs-CRP) 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 (hs-CRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum.
Recall Number Z-1178-2013
Classification Class II
Code Info Model Number 12-807. · Lot/Unit Codes: 274632, 281847 · Expiration date, or Expected shelf life: 5/5/13, 6/30/13
Product Distributed Qty 2333 kits
Reason For Recall The Alere Cholestech LDX® hsCRP cassette (PN 12807) 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.

Event Detail

Event Id 64701
Product Type Devices
Status Ongoing
Recalling Firm Alere San Diego, Inc.
City San Diego
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-06
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern USA Nationawide Distribution