| Class 2 Device Recall Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JJE
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