Ortho Diagnostics Vitros Chemistry Analyzer

Company: Ortho-Clinical Diagnostics, Inc.
Date of Enforcement Report: 3/21/01
Date of recall letter: 6/26/00
Class: II

PRODUCT:

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.

REASON:

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.

CODE:

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).
MANUFACTURER:

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

RECALLED BY:

Manufacturer, by letter on June 28 and October 6, 2000.
Firm-initiated recall ongoing.

DISTRIBUTION:

Nationwide and International.

QUANTITY:

a) 279 devices; b) 18 devices.

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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