Recall Z-1028-2013— Roche Diagnostics Operations, Inc.

Name: FDA recall Z-1028-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-01

Class II · Terminated

Class II FDA medical device recall by Roche Diagnostics Operations, Inc., initiated 2013-03-01, terminated 2014-06-04. It names one FDA 510(k) clearance: K110923. Product: Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas¿ CT/NG 4800 System, for in vitro diagnostics.. Reason: Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir. As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead to delayed results and wasted reagent..

Recalling firm: Roche Diagnostics Operations, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-03-01
Terminated: 2014-06-04
Firm location: Indianapolis, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K110923 — COBAS 4800 CT / NG TESTRoche Molecular Systems, Inc.·cleared 2012-01-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas¿ CT/NG 4800 System, for in vitro diagnostics.

Reason for recall

Certain lots of Reagent reservoirs, may not have a separation in the lower part of the reservoir. As a consequence, pipetting errors can occur due to uneven distribution of reagent. These pipetting errors may lead to delayed results and wasted reagent.

Data sourced from openFDA. This site is unofficial and independent of the FDA.