INC Class II SANGUIN INTL.

Company: SANGUIN INTL., INC
Date of Enforcement Report: 9/12/01
Class: II

RECALL NUMBER, PRODUCT AND CODE:
Z-1048-1
Medusa 2000 MED20SP Link Software Versions 1.2 and 1.3 The software Medusa 2000 is an interface link to the Ortho Summit Processor (OSP) which is a mass processing device for microplate based assays [tests for viral markers by ELISA]. The software is responsible for conveting OSP files into a format for use by Medusa 2000.

REASON:
Software may process result instead of invalidating the plate

CODES:
Medusa 2000 MED20SP Link Software Versions 1.2 and 1.3

MANUFACTURER/RECALLING FIRM:
SANGUIN INTL., INC. STAFFORDSHIRE DE 13 8AX,

RECALLED BY:
SANGUIN INTL., INC. HAMDEN, CT, by letter on 6/12/01

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
AL and TN

QUANTITY:
2

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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