Z-0150-2007

Home Access-Hepatitis C Check; At Home Telemedicine Test Service for Hepatitis C ; each kit is composed of an...

Name: Z-0150-2007 Home Access-Hepatitis C Check; At Home Telemedicine Test Service for Hepatitis C ; each kit is composed of an...
Creator: Home Access Health Corp (HAHC)
Published: 2006-10-06
License: https://open.fda.gov/license/

Home Access Health Corp. / initiated 2006-10-06 / Terminated / root cause: labeling and UDI

FDA source

Home Access Health Corp (HAHC) began a recall of 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... on 2006-10-06. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0150-2007
Status: Terminated
Initiated: 2006-10-06
Posted: 2006-11-04
Terminated: 2007-05-31
Recalling firm: Home Access Health Corp.
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
Product code: MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
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.
Root cause tag: labeling and UDI
FDA root cause: Other
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
Product codes and lots: 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

Product code MZO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)