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U.S. Department of Health and Human Services

Class 2 Device Recall Elecsys 2010 Analyzer Software version 0607

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  Class 2 Device Recall Elecsys 2010 Analyzer Software version 0607 see related information
Date Initiated by Firm January 31, 2012
Date Posted March 16, 2012
Recall Status1 Terminated 3 on September 06, 2012
Recall Number Z-1218-2012
Recall Event ID 60934
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 IN 46256-1025
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JJE and Original Applicant = BOEHRINGER MANNHEIM CORP.
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