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U.S. Department of Health and Human Services

Class 2 Device Recall Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges

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  Class 2 Device Recall Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges see related information
Date Initiated by Firm August 31, 2011
Date Posted October 19, 2011
Recall Status1 Terminated 3 on January 14, 2014
Recall Number Z-0069-2012
Recall Event ID 59889
510(K)Number K081643  
Product Classification troponin in vitro diagnostic - Product Code JJE
Product Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges
Code Information Lot Numbers ED2098, EA2111, FB2134, ED2147
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
500 Gbc Dr Ms 514
PO BOX 6101
Newark DE 19702-2466
For Additional Information Contact Roberty J. King
800-441-9250
Manufacturer Reason
for Recall		 Firm has confirmed customer complaints for low recovery of QC and patient samples.
FDA Determined
Cause 2		 Process control
Action Siemens Healthcare Diagnostics, Inc. Urgent Field Safety Notice was sent to customers on August 31, 2011 regarding the issue. The letter instructs customers to immediately discontinue use of the affected lots and discard all remaining inventory.
Quantity in Commerce 6,072 cartons
Distribution Worldwide distribution: USA, Puerto Rico, Guam, Austria, Canada, Croatia, France, Greece, Germany, Italy, Japan, Mexico, Portugal, 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 = SIEMENS HEALTHCARE DIAGNOSTICS
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