FDA Medical Device Recalls (openFDA)
OraSure Technologies, Inc.: OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.
- Recall number
- Z-1509-2016
- Recalling firm
- OraSure Technologies, Inc.
- Product
- OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of detection of the device.
- Status
- Terminated
- Initiated
- 2016-01-15
- Posted
- not on file
- Terminated
- 2018-02-07
- Reason
- OraSure Technologies, Inc. discovered the package insert included with the OraQuick HCV Rapid Antibody test Visual Reference Panel may be incorrect due to a complaint received from one of their customers. The customer reported they received the Ora Quick Ebola Visual Reference Panel instead of an OraQuick HCV Visual Reference Panel.
- Root cause
- Unknown/Undetermined by firm
- Action
- Letters, dated January 15, 2016, and correct HCV VRP insert were sent to all customers who received HCV VRP lot 6648737. The letter stated the reason for the recall; and, asked users to discard the Package Insert that was included with the product and replace it with the corrected one provided with the letter. Questions regarding the recall should be directed to OraSure Sales Representative or our Customer Care Department at 1-800-ORASURE.
- Quantity
- 244 Visual Reference Panel Kits
- Distribution
- Nationwide Distribution -- AK, AL, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KY, LA, MA, MI, MO, MT, NC, ND, NE, NH, NM, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, and WI.
- Lot, serial or model codes
- Item Number 1001-0343, Lot # 6648737
- 510(k) numbers
- not on file
- PMA numbers
- ["P080027"]
- Product code
- MZO
- Firm FEI
- 2528909
- Firm city
- Bethlehem
- Firm state
- PA
- 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