FDA Medical Device Recalls (openFDA)
Home Access Health Corp (HAHC): 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
- Recall number
- Z-0150-2007
- Recalling firm
- Home Access Health Corp (HAHC)
- 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
- Status
- Terminated
- Initiated
- 2006-10-06
- Posted
- 2006-11-04
- Terminated
- 2007-05-31
- Reason
- 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
- 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
- 13,911 kits
- Distribution
- Nationwide
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- ["P980046"]
- Product code
- MZO
- Firm FEI
- 3000206414
- Firm city
- Hoffman Estates
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28