Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall IMMULITE/IMMULITE 1000 Turbo Troponin I

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


New Search Back to Search Results
  Class 2 Device Recall IMMULITE/IMMULITE 1000 Turbo Troponin I see related information
Date Initiated by Firm October 27, 2014
Date Posted December 12, 2014
Recall Status1 Terminated 3 on March 10, 2017
Recall Number Z-0801-2015
Recall Event ID 69718
510(K)Number K991795  
Product Classification Immunoassay method, troponin subunit - Product Code MMI
Product Turbo Troponin I

For in vitro diagnostic use for the quantitative measurement of troponin I in serum, heparinized or EDTA plasma, as an aid in the diagnosis of acute myocardial infarction (AMI).
Code Information Catalog #'s: 1) LSKTI1 and 2) LSKTI1(D); Siemens Material Number (SMN): 1) 10642238 (US) and 2) 10381014 (OUS); Lot Numbers: 319, 321, 322, 323 and D319, D321 and D322.  
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact
914-631-8000
Manufacturer Reason
for Recall
FDA Determined
Cause 2		 Under Investigation by firm
Action The firm, Siemens, sent an "Urgent Medical Device Recall" letter dated October 27, 2014 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of and discard the kit lots listed; review this letter with your Medical Director, complete and return the Field Correction Effectiveness Check attached to this letter within 7 days via fax to: the Customer Care Center at (312) 275-7795; report any complaints or AE associated with the product to your local Siemens Customer Care Center or your local Siemens technical support representative; contact your local Siemens technical support representative to discuss alternative Siemens solutions; retain this letter with your laboratory records, and forward this letter to those who may have received this product. If you have any questions, contact your local Siemens technical support representative or 914-524-3074.
Quantity in Commerce 3,622 kits (3,572 domestic and 50 internationally)
Distribution Worldwide Distribution: US distribution in states of: CO, FL, MN, MT, and NY; and countries of: Algeria, Argentina, Bolivia, Brazil, Bulgaria, Chile, Columbia, Czech Republic, Ecuador, Egypt, Germany, Hungary, India, Italy, Lithuania, Latvia, Pakistan, Poland, Romania, Russian Fed., Serbia, South Africa, Slovakia, Thailand, Tunisia, and Uruguay.
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 = MMI and Original Applicant = DIAGNOSTIC PRODUCTS CORP.
-
-