28
Dec
1999

Ortho Vitros Immuno Analyzer Class II

0

REASON

Software error in Vitros ECi Immunodignostic system.

PRODUCT

Vitros Immunodiagnostic System, a random access immunodiagnostic
analyzer for quantitative and qualitative determination of
analytes in human specimens. Recall #Z-360-0.

CODE

Catalog #8633893, Serial #30000054-30001120.

MANUFACTURER

Ortho-Clinical Diagnostics, Inc., Rochester, New York.

RECALLED BY

Manufacturer, by letters dated December 28, 1999, and January 13,
2000, and by Technical Bulletin (J11664). Firm-initiated field
correction ongoing.

DISTRIBUTION

Nationwide and international.

QUANTITY

1,066 units were distributed.

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.

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