Z-2142-2024Class II

VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X...

Name: Z-2142-2024 VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X...
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2024-03-01
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2024-03-01 / Open, Classified

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 -... on 2024-03-01. FDA classified it as Class II and gives the reason as "Potential for positively biased results due to signal reduction over shelf life". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2142-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-01
Posted: 2024-06-13
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled Calibrator tube (1 per level: C1 - green, C2 - yellow, C3 - red).
Product code: LOM Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
Reason for recall: Potential for positively biased results due to signal reduction over shelf life.
FDA root cause: Under Investigation by firm
Action: Consignees were mailed an URGENT PRODUCT CORRECTION NOTIFICATION, dated 5/14/24. In this notice consignees are instructed to discontinue using, render unusable, and discard affected product. The provided notification is to be retained and posted by each VITROS System until the issue has been resolved; copies of the recall notification are to be forwarded if affected product was distributed outside your facility. Consignees are to complete and return the provided Confirmation of Receipt form no later than 5/22/24. Consignees with any questions are to contact Quidel Ortho's Global Services Organization at 1-800-421-3311.
Quantity in commerce: 481 units
Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, FL, GA, IA, IL, IN, KS, LA, MA, MD, ME, MI, MT, NC, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WI, WV and the countries of Bermuda, Colombia, Singapore.
Product codes and lots: Model No. 6801926; GTIN# 10758750001699; Lot 9010 (Manufactured 13-Oct-2023; Expiry 15-Jul-2024) and 9030 (Manufactured 09-Dec-2023; Expiry 26-Aug-2024).

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2142-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2142-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-06-19	2024-06-13

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)