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
