Cl II Ortho Verseia Pipetter (VERSEIA)

Company: Ortho Clinical Diagnostics Inc
Date of Enforcement Report: 11/6/2013
Class lI:

PRODUCT

Ortho Verseia Pipetter (VERSEIA) Recall Number B-2518-13

REASON
ORTHO VERSEIA Pipetter software, with a defect or glitch that in certain circumstances during plate processing, has the potential for false negative results.

RECALLING FIRM/MANUFACTURER
Ortho Clinical Diagnostics Inc, Raritan, NJ on 8/21/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
4

DISTRIBUTION
Nationwide

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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.