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.

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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