Ortho Vitros 250 Analyzer Class III

Company: Ortho-Clinical Diagnostics, Inc.
Date of Enforcement Report: 3/7/01
Date of recall: 6/28/00
Class: III

PRODUCT:

Vitros 250 Chemistry Systems with Software Versions 6.x
(6.0,6.01, 6.02, etc). Recall #Z-249-1.

REASON:

Test results may be mis-reported as 0.0 for any analyte
including CK-MB, acetaminophen, iron, lithium, and
salicylate.

CODES:

Catalog #8132086. Vitros 250 Chemistry System serial
numbers less than 2501494.

MANUFACTURER:

Ortho-Clinical Diagnostics, Inc., Rochester, NY.

RECALLED BY:

Manufacturer, by letter on June 28, 2000. Firm-
initiated recall ongoing.

DISTRIBUTION:

Nationwide and worldwide. There are 209 Federal
government accounts under government contract #GS-24f-
1243c.

QUANTITY:

1,780 – domestic; and approx. 2,700 – international.