Ortho-Clinical Diagnostics Issues Class I Recall on Vitros Immunodiagnostic Products

The Food and Drug Administration (FDA) released the following information:

Class 1 Medical Device Recalls - Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Signal Reagent

Product:
 VITROS Immunodiagnostic Products Signal Reagent, Lot 8350, catalog #107 2693
VITROS Immunodiagnostic Products Signal Reagent, Lot 8530, catalog #107 2693
 
Use:
 This reagent is a special chemical used with the VITROS Immunodiagnostic ECi/ECiQ System to screen patient samples and diagnose more than 40 diseases and conditions including cardiac disease, hepatitis (A, B or C), thyroid disorders, HIV and pregnancy.
 
Recalling Firm:
 Ortho-Clinical Diagnostics
100 Indigo Creek Dr
Rochester , New York 14626-5101
 
Reason for Recall:
 A decreased signal in the reagent may produce inaccurate results in some cases, affecting the outcome of the diagnostic tests.
 
Public Contact:
 Judy M. Strzepek
Director, WW Quality Systems and Compliance
Ortho-Clinical Diagnostics, Inc.
1001 U.S. Highway 202
Raritan, NJ 08869
908-218-8524
 
FDA District:
 New York Downstate
 
FDA Comments:
 Customers with the affected lot numbers should discontinue using any remaining VITROS Immunodiagnostic Products Signal Reagent, Lot 8350 or 8530.
Customers should follow the enhanced Quality Control (QC) procedure provided by Ortho-Clinical Diagnostic for each pack in all lots of VITROS Signal Reagent until further notice.
Patients who have had diagnostic testing performed for any of these medical conditions within the last 60 days and are concerned with their test results should discuss them with their physicians: cardiac disease, hepatitis (A,B, or C), thyroid disorders, HIV and pregnancy.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
 
 A copy of Ortho-Clinical Diagnostics' (a Johnson & Johnson company) press release about this recall can be found on the company's website.


Type of Recall:
Class I - This is a health hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death.