Z-1509-2016Class III

OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading...

Name: Z-1509-2016 OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading...
Creator: OraSure Technologies, Inc.
Published: 2016-01-15
License: https://open.fda.gov/license/

OraSure Technologies, Inc. / initiated 2016-01-15 / Terminated / root cause: labeling and UDI

FDA source

OraSure Technologies, Inc. began a recall of OraQuick HCV Visual Reference Panel Intended to assist new operation in becoming proficient at reading specimens with antibody levels near the limit of... on 2016-01-15. FDA classified it as Class III and gives the reason as "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...". 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-1509-2016
Classification: Class III
Status: Terminated
Initiated: 2016-01-15
Posted: 2016-04-18
Terminated: 2018-02-07
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.
Product code: MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Item Number 1001-0343, Lot # 6648737

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1509-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1509-2016	Class III	Terminated	Voluntary: Firm initiated	2016-04-27	2016-04-18

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)