Z-1161-2013Class III

VITROS Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent...

Name: Z-1161-2013 VITROS Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent...
Creator: Ortho-Clinical Diagnostics
Published: 2012-11-01
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2012-11-01 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination... on 2012-11-01. FDA classified it as Class III and gives the reason as "Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1161-2013
Classification: Class III
Status: Terminated
Initiated: 2012-11-01
Posted: 2013-04-23
Terminated: 2017-03-30
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Immunodiagnostic Products Anti-HBs (total antibody to hepatitis B surface antigen (anti-HBs)) Reagent Packs For the quantitative in vitro determination of total antibody to hepatitis B surface antigen (anti-HBs) in human serum.
Product code: LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Reason for recall: Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: Ortho Clinical Diagnostics (OCD) sent an Urgent Product Correction Notification letter dated November 1, 2012, to all affected customers via USPS. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to discontinue and discard any remaining recalled lots of VITROS Anti-HBS Reagent Packs. Foreign affiliates were informed by email on November 1, 2012, of the issue and instructed to notify their consignees of the issue and actions . On March 22, 2013, OCD sent customer letters via FedEX overnight and/or via USPS to US consignees for two additional lots of product being recalled. The letter provided similar recall instructions as the initial notification. Ortho Clinical Diagnostics has requested that their clients discontinue and discard any remaining inventory of VITROS Anti-HBS Reagent Packs subject to this recall. OCD has also requested that recall product recipients also complete a Confirmation of Receipt and return that document to OCD, fax to: 1-888-557-3759 or 585-453-4110. We apologize for any inconvenience this may cause your laboratory. If you have technical questions please contact Customer Technical Services at 1-800-421-3311. If you have questions about your replacement order, please call our Customer Service Center at 1-800-828-6316.
Quantity in commerce: 1464 units
Distribution: Worldwide Distribution- USA (nationwided) and countries of: Australia, Brazil, Canada, Chile, Chao Yang District, Beijing, Columbia, England, France, Germany, India, Italy, Japan, Mexico, Republic of Panama, Singapore, Spain and Venezuela.
Product codes and lots: Lot #'s 6630 expiration 2/26/2013, Lot # 6740 expiration 6/18/2013 and Lot # 6750 expiration date 6/11/2013.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1161-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1161-2013	Class III	Terminated	Voluntary: Firm initiated	2013-05-01	2013-04-23

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)