• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Elecsys 2010 Analyzer Software version 0607

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
 Class 2 Recall
Elecsys 2010 Analyzer Software version 0607
see related information
Date Posted March 16, 2012
Recall Status1 Terminated on September 06, 2012
Recall Number Z-1218-2012
Recall Event ID 60934
Premarket Notification
510(K) Number
K961481 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - Product Code JJE
Product Elecsys 2010 Analyzer Software version 06-07 The Elecsys 2010 analyzer is intended for the in vitro quantitative and qualitative analysis of analytes in body fluids.
Code Information Elecsys 2010 Analyzer Rack: 11804014001 Elecsys 2010 Analyzer Disk: 11568248001 Software version 06-07: 06526080001, 06569668001
Recalling Firm/
Manufacturer
Roche Diagnostics Operations, Inc.
9115 Hague Road
Indianapolis, Indiana 46256-1025
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Betsy Cox
317-521-3911
Manufacturer Reason
for Recall
Elecsys 2010 customers have reported getting no value and flag 48 results below expected value range after performing automatic dilution for a sample that previously recovered above the measuring range. Incorrect but believable results may occur for the CEA, Rubella IgG or SHBG assays. The other affected assays will generate either no value or a negative result, both of which are not bel
FDA Determined
Cause 2
DESIGN: Software Design
Action Roche sent an Urgent Medical Device Correction letter dated January 31, 2012, via UPS Ground (receipt required) to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: use one of the workarounds outlined in this Urgent Medical Device Correction (UMDC) if you are running an automatic dilution on an Elecsys 2010 analyzer with software version 06-07; complete the attached faxback form (4600-00-0112) and fax it to 1-888-912-8460; and file this UMDC for future reference. For questions regarding this recall call 1-800-428-2336.
Quantity in Commerce Software version 06-07 was installed on Elecsys 2010 analyzers at 13 accounts.
Distribution Worldwide Distribution - USA including NY, GA, DE, SD, WI, ME, OR, IA, AND CA and the countries of Austria, Cyprus, Czech Republic, Estonia, France, Germany,Greece, Hungary, Iceland, Italy, Latvia, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Switzerland
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = BOEHRINGER MANNHEIM CORP.
-
-