Home / Recalls / Medical Devices
Roche Diagnostics Corporation recalls Roche cobas p 612 pre-analytical system (63x) Model: 07563116001 The cobas p 612 pre-analytical system is a compute
Recalled September 5, 2018 · FDA recall Z-2944-2018 · Roche Diagnostics
Hazard
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. · FDA Class II
Units
12 units
Sold at
US Distribution to states of: CA, NY,TX, WA, and WI.
Description
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.
Product
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.
Manufacturer(s)
Roche Diagnostics Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →