Z-0687-2019Class II

VITROS Anti-HBe Reagent Pack, Cat No. 6801816

Name: Z-0687-2019 VITROS Anti-HBe Reagent Pack, Cat No. 6801816
Creator: Ortho-Clinical Diagnostics
Published: 2018-11-01
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2018-11-01 / Open, Classified / root cause: design

FDA source

ORTHO-CLINICAL DIAGNOSTICS began a recall of VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human... on 2018-11-01. FDA classified it as Class II and gives the reason as "The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0687-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-11-01
Posted: 2019-01-03
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Anti-HBe Reagent Pack, Cat No. 6801816 Product Usage: For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from HBV infection, using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System. Further assessment of HBV infection (biochemical, serological and/or nucleic acid testing) is required to define the specific disease state. VITROS Anti-HBe test performance has not been established for the monitoring of HBV disease or therapy. Test performance characteristics have not been established in patients under the age of 2, or in populations of immunocompromised or immunosuppressed patients. This test has not been FDA licensed for the screening of blood, plasma and tissue donors.
Product code: LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Reason for recall: The firm is extending their previous July 2018 recall to include additional product codes. Biased results may occur for these additional products at biotin concentrations which are lower than indicated in the current Instructions for Use.
Root cause tag: design
FDA root cause: Device Design
Action: On November 1, 2018, a customer letter was sent via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail to all customers who could process the affected products to inform them of the potential interference of biotin at levels lower than stated in the IFUs and that Ortho is in the process of revising the IFUs for the affected products. Ortho recommended customers follow normal laboratory procedures for troubleshooting of samples containing other assay interferences and it was acceptable to continue using the affected products. If you have questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
Quantity in commerce: 3429 units (100 tests per unit)
Distribution: Worldwide Distribution - US Nationwide domestic distribution. International distribution to Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, India, France, Japan, Germany, Italy, Mexico, Norway, Poland, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, and United Kingdom.
Product codes and lots: All expired, in-date, and future lots released.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0687-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0687-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-01-09	2019-01-03
Z-0688-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-01-09	2019-01-03
Z-0689-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-01-09	2019-01-03

Product code LOM

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)