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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 Recall
Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges
see related information
Date Posted October 19, 2011
Recall Status1 Terminated on January 14, 2014
Recall Number Z-0069-2012
Recall Event ID 59889
Premarket Notification
510(K) Number
K081643 
Product Classification Analyzer, Chemistry (Photometric, Discrete), For Clinical Use - 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, Delaware 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
PRODUCTION CONTROLS: 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 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 = SIEMENS HEALTHCARE DIAGNOSTICS
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