Roche Diagnostics Corporation recalls Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer co…

Recall date

July 16, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2944-2018

FDA classification

Class II

Brand / firm

Roche Diagnostics Corporation

Sold / distributed

US Distribution to states of: CA, NY,TX, WA, and WI.

Why it was recalled

Sample material may potentially come in contact with the pipetting nozzle during operation of cobas p 612 pre-analytical system (63x) (LCP1) with non-filter tips. The possible presence of biological material on the nozzle may cause contamination resulting in potential false positive results, depending on the sensitivity of the analytical technology.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged and non-centrifuged sample tubes. The cobas p 612 is intended for use with analyzers that perform tests in the area of clinical chemistry, immuno chemistry, coagulation, hematology, urinalysis, nucleic acid testing.