Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

cobas c 311 Analyzer, Part Number: 04826876001 In-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.

FDA Recall Z-0310-2012 · Posted 2011-11-30

Recalling FirmRoche Diagnostics Operations, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2011-10-26
Date Terminated2012-07-09
Product Quantity940 worldwide

Reason for Recall

The cobas c 311 analyzer software may incorrectly calculate the volume of the ISE Reference Electrolyte solution remaining on the analyzer. In some cases the incorrect results obtained will not be flagged with any data alarms.

Firm Action

October 26, 2011 Urgent Medical Device Corrections were sent to all direct accounts in the USA that have installed the cobas c 311 analyzer and included a faxback form to be completed and faxed to 1-877-766-7452. Consignees were instructed to temporarily replace the ISE Reference Electrolyte bottle based upon the frequency calculated from the maximum number of ISE samples run per day and activate the yellow threshold alarm on the system. Customers with question and concerns are directed to call Roche Diagnostics Technical Support at 1-800-428-2366, available 24-hours, 7 days a week.

Root Cause

Software design

Distribution Pattern

Worldwide Distribution -- USA including the states of Maryland and Texas.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑