Ortho-Clinical Diagnostics: Medical Device Recall in 2014 - (Recall #: Z-0557-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 25, 2013

Date Posted: January 1, 2014

Recall Number: Z-0557-2014

Event ID: 66900

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.

Status: Terminated

Product Quantity: 1,920 kits

Code Information:

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

Distribution Pattern:

Nationwide distribution - all states.

Voluntary or Mandated:

Voluntary: Firm initiated