Z-2671-2014Class II

VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G...

Name: Z-2671-2014 VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G...
Creator: Ortho-Clinical Diagnostics
Published: 2014-08-06
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2014-08-06 / Terminated / root cause: packaging

FDA source

ORTHO-CLINICAL DIAGNOSTICS began a recall of VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human... on 2014-08-06. FDA classified it as Class II and gives the reason as "VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expected VITROS Anti-HCV test results due to an approximate signal loss of up to 66.2% which can result in...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2671-2014
Classification: Class II
Status: Terminated
Initiated: 2014-08-06
Posted: 2014-09-19
Terminated: 2017-04-14
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunoglobulin G antibody to hepatitis C virus (anti-HCV) in human serum and plasma. REF 680 2454, IVD -- Ortho-Clinical Diagnostics High Wycombe UK. Note that one sales unit has 5 Reagent Packs contained within it. Each Reagent Pack can test for 100 samples (patient, Quality Control, etc.).
Product code: MZO Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus
Reason for recall: VITROS Immunodiagnostic Products Anti-HCV kit lot 9090 has been observed producing sporadic lower than expected VITROS Anti-HCV test results due to an approximate signal loss of up to 66.2% which can result in unexpected negative test results being obtained for reactive sample fluids (quality control and patient samples).
Root cause tag: packaging
FDA root cause: Packaging process control
Action: All US consignees (users) who were shipped the affected lot VITROS HCV Reagent Pack were sent communications via FedEx and/or US Priority Mail (PO Boxes only) on 8/06/14, and advised of the issue and to immediately discontinue using all remaining inventory of VITROS Anti-HCV Reagent Packs Lot 9090. For additional information, please contact OCD's Customer Technical Service representatives at 1-800-421-3311.
Quantity in commerce: 463 sales units
Distribution: NY, NJ, CT, MA, PA, VA, MD, FL and GA
Product codes and lots: Lot 9090 (exp. December 15, 2014)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2671-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2671-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-19

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)