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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Model Number 12-807. · Lot/Unit Codes: 274632, 281847 · Expiration date, or Expected shelf life: 5/5/13, 6/30/13 Class II 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. 2333 kits Z-1178-2013