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U.S. Department of Health and Human Services

Class 3 Device Recall Home Access Hepatitis C Check

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 Class 3 Recall
Home Access Hepatitis C Check
see related information
Date Posted November 04, 2006
Recall Status1 Terminated on May 31, 2007
Recall Number Z-0150-2007
Recall Event ID 36429
Premarket Approval
PMA Numbers
P950002 P980046
Product Classification Assay,Enzyme Linked Immunosorbent,Hepatitis C Virus - Product Code MZO
Product Home Access-Hepatitis C Check; At Home Telemedicine Test Service for Hepatitis C ; each kit is composed of an outer box, a shrink-wrapped inner box that contains the blood collection card with an unique PIN, the instructions for use and ''Frequently Asked Questions'', a polybag component that includes two lancets, one gauze pad, one adhesive bandage and one alcohol prep pad, a specimen return envelope and a prepaid return mailer either designated as U.S. first class or FedEx; Home Access Health Corporation, Hoffman Estates, IL 60195-5200; UPC 0 83170 51000 5
Code Information UPC 0 83170 61000 2: lot 042715, exp May 2007; lot 042716, exp June 2007; lot 042717, exp June 2007; lot 042718, exp June 2007; lot 042719, exp August 2007; lot 042720, exp August 2007; lot 042721, exp August 2007; lot 042722, exp August 2007; lot 042723, exp October 2007; lot 042724, exp October 2007; lot 042725, exp October 2007; lot 042726, exp October 2007; lot 042727, exp October 2007; lot 052703, exp November 2007; lot 052704, exp November 2007; lot 052705, exp November 2007; lot 052706, exp November 2007; lot 052708, exp November 2007; lot 052709, exp January 2008
Recalling Firm/
Manufacturer
Home Access Health Corp (HAHC)
2401 Hassell Rd Ste 1510
Hoffman Estates, Illinois 60195-5241
For Additional Information Contact Ms. Mary E. Vogt
800-871-6046
Manufacturer Reason
for Recall
Wrong Expiration Date; The kits were labeled with Expiration/Use By dates; that exceed the expiration dates of the sterile safety lancet component of the kit.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Recall letters dated 10/6/06 were sent to the direct accounts via FedEx on the same date. The accounts were informed of incorrect Use By dates on the kits based on the lancet component of the kit, and that the lancet may not be sterile as of the printed Use By date on the kit. The letters listed the specific products and affected lot numbers shipped to the individual account, and requested them to examine their inventory for the affected product and return it via UPS to Home Access for replacement. No test results will be provided to any customer who uses the affected product after 10/31/06. Any questions were directed to 1-800-871-6046.
Quantity in Commerce 13,911 kits
Distribution Nationwide
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = MZO and Applicant = CENTERPULSE SPINE-TECH, INC.
PMAs with Product Code = MZO and Applicant = SPINE-TECH, INC.
PMAs with Product Code = MZO and Applicant = SPINTECH, INC.
PMAs with Product Code = MZO and Applicant = SULZER SPINE-TECH
PMAs with Product Code = MZO and Applicant = ZIMMER SPINE, INC
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