Company: Ortho-Clinical Diagnostics, Inc.
Date of Enforcement Report: 3/21/01
Date of recall letter: 6/26/00
a) Vitros 250 and Vitros 250 AT Chemistry Systems Software version
below 7.0.; Recall #Z-386-1.
b) Vitros 950 and Vitros 950AT Chemistry Systems with
software version below 3.07. Recall #Z-387-1.
The Bilirubin (Unconjugated Bilirubin) results may be reported as
0.0 mg/dL or Bc (Conjugated Bilirubin) result may not be flagged
with a potential interferent code when a spectral interferent is
present in a patient sample.
a) Model No. 3332, Catalog No. 8132086 (Vitros 250);
Model No. 3391, Catalog No. 1558143 (Vitros 250AT);
b) Model No. 3360, Catalog No. 8748790 (Vitros 950);
Model No. 3361, Catalog No. 1735356 (Vitros 950AT).
Ortho-Clinical Diagnostics, Inc., Rochester, NY.
Manufacturer, by letter on June 28 and October 6, 2000.
Firm-initiated recall ongoing.
Nationwide and International.
a) 279 devices; b) 18 devices.