Z-0557-2014Class II

VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs

Name: Z-0557-2014 VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
Creator: Ortho-Clinical Diagnostics
Published: 2013-10-25
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2013-10-25 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs on 2013-10-25. FDA classified it as Class II and gives the reason as "Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive results". 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-0557-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-25
Posted: 2013-12-20
Terminated: 2018-05-18
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Anti-HBs Calibrators & VITROS Anti-HBs Reagent Packs
Product code: LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Reason for recall: Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Immunodiagnostic Products Anti-HBs Calibrators and Anti-HBs Quantitative Reagent Packs due to false positive results.
Root cause tag: manufacturing process
FDA root cause: Other
Action: On October 25, 2013, Ortho Clinical Diagnostics issued product correction notifications to their US customers via US Postal Service Priority Mail and email notices to their foreign affiliates informing them of the recall. Ortho Clinical Diagnostics advised their customers to review previously reported results between > 12 and <30 mIU/mL and consult the Laboratory Medical Director. Customers were instructed to utilize alternative methods for anti-HBs testing. Customers are advised to seek alternative methods for anti-HBs testing. For additional information, please contact the OCD Customer Technical Service representative at 1-800-421-3311.
Quantity in commerce: 1,920 kits
Distribution: Nationwide distribution - all states.
Product codes and lots: Product Code 1) 6801926, 2) 6801925, 3) 6802452 Lot numbers: 1) 6700, 2) 6731, 3) 6830 Expiry Dates: 1) 21 May 2013, 2) 24 July 2013, 3) 11 Sept 2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0557-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0557-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-20

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)