Cobas 8000 Modular Analyzer Series, Model/Catalog/Part Number: 05641489001. The Cobas 8000 is a fully automated system f

FDA device recall Z-0473-2013 · posted 2012-12-04 · Terminated

Recall details

Recalling firm

Roche Diagnostics Operations, Inc.

Reason for recall

On cobas c 701 and cobas c 702 modules of the Cobas 8000 series analyzer, a mismatch between the reagent probe positioning and the aspirated reagent volumes under certain conditions can lead to insufficient reagent pipetting. This may affect patient sample and controls recovery for the following tests: Alkaline Phosphatase (ALP2), Alanine Aminotransferase (ALT), Bicarbonate (CO2-L), Creatinine (C

Action taken

On 11/01/2012 an "Urgent Medical Device Correction" notification was sent via UPS Ground (receipt required) to consignees. The device issue was described and recommended actions were provided. A Roche Field Application Specialist will install the new e-barcode during a scheduled visit. Customers also will have an option to install the new e-barcodes themselves, following the instructions provided in the notification. A Software update will be released when available. Customers may contact Technical Support at 1-800-428-2336 for more information.

Root cause

Software design

Status

Terminated

Product code

JJE

Quantity affected

78 analyzers

Distribution

Nationwide Distribution, including the states of AL, AZ, CA, FL, GA, IL, IN, KS, KY, MA, MD, MI, MN, NC, NJ, NY, OH, VA, WA, and WI.

Date initiated

2012-11-01

Date posted

2012-12-04

Date terminated

2014-01-08

Location

Indianapolis, IN