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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Event Detail

Event ID 65048
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 2013-04-16
Initial Firm Notification of
Consignee or Public
Distribution Pattern United States Nationwide Distribution

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Alere" hCG Combo Cassette (20/10 mIU/mL) Kit. Product Usage: The AlereTM hCG Combo (20/10 mIU/mL) test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine, as an aid in the early detection of pregnancy. It is for healthcare professionals only. Lot/Unit Codes: hCG1110133 & hCG1110135 Part Number: 92215 Expiration date, or Expected shelf life: 9/30/13 & 10/31/13 Class II The firm initiated recall of Alere" hCG Combo Cassette (20/10 mIU/mL) kit PN 92215, lots hCG1110133 and hCG1110135, because an investigation has indicated a portion of these Alere" hCG Combo Cassette (20/10 mIU/mL) PN 92215 kit lots were incorrectly packaged with the Alere" hCG Cassette (20 mIU/mL) PN 92210 Product Insert. The Alere" hCG Cassette (20 mIU/mL) Product Insert contains information for hCG urine testing but lacks information for performing the hCG serum testing using the Alere" hCG Combo Cassette product. 3975 kits Z-1401-2013