Ortho-Clinical Diagnostics: Medical Device Recall in 2013 - (Recall #: Z-1161-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class III

Date Initiated: November 1, 2012

Date Posted: May 1, 2013

Recall Number: Z-1161-2013

Event ID: 64739

Reason for Recall:

Ortho Clinical Diagnostics is recalling certain lots of the Vitros Anti-HBs Reagent packs an inability to obtain a valid calibration.

Status: Terminated

Product Quantity: 1464 units

Code Information:

Lot #'s 6630 expiration 2/26/2013, Lot # 6740 expiration 6/18/2013 and Lot # 6750 expiration date 6/11/2013.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated