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U.S. Department of Health and Human Services

Class 2 Device Recall Alere hCG Combo Cassette (20/10 mIU/mL) KIt

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  Class 2 Device Recall Alere hCG Combo Cassette (20/10 mIU/mL) KIt see related information
Date Initiated by Firm April 16, 2013
Date Posted May 25, 2013
Recall Status1 Terminated 3 on October 18, 2013
Recall Number Z-1401-2013
Recall Event ID 65048
510(K)Number K062361  
Product Classification Visual, pregnancy hCG, prescription use - Product Code JHI
Product 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.
Code Information Lot/Unit Codes: hCG1110133 & hCG1110135  Part Number: 92215  Expiration date, or Expected shelf life: 9/30/13 & 10/31/13
Recalling Firm/
Manufacturer		 Alere San Diego, Inc.
9975 Summers Ridge Rd
San Diego CA 92121-2997
For Additional Information Contact
858-805-2000 Ext. 3015
Manufacturer Reason
for Recall		 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
FDA Determined
Cause 2		 Packaging
Action Alere initiated this recall by sending recall notification letters, titled "URGENT MEDICAL DEVICE RECALL", dated April 16, 2013 via via fax, email or direct mail. The letter informed customers of the product recalled, reason for recall, customer required action, and contact information, "Alere Technical Services at 866-216-0094 or by e-mail at lateral.flow.support@alere.com.". A verification form was attached to the notification letter.
Quantity in Commerce 3975 kits
Distribution United States Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JHI and Original Applicant = INNOVACON, INC.
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