| Class 2 Device Recall Dimension Troponin 1 | |
Date Initiated by Firm | March 21, 2017 |
Date Posted | May 05, 2017 |
Recall Status1 |
Terminated 3 on August 03, 2018 |
Recall Number | Z-2606-2017 |
Recall Event ID |
76915 |
510(K)Number | K081643 |
Product Classification |
Immunoassay method, troponin subunit - Product Code MMI
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Product | Dimension Troponin 1 (TNI) Flex reagent cartridge |
Code Information |
Device Listing Number # D056469 Lot # EB7091, EC7104, EA7125, ED7193, EA7161, EB7173, EC7229, ED7236 EA7250, ED7271, EB7315, EB7342 " |
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 | 800-441-9250 |
Manufacturer Reason for Recall | The concentrations for Biotin listed in the Non-Interfering Substances section of the current Dimension and Dimension Vistat Instructions for Use (IFU) for Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH have incorrect units, and incorrectly state the level at which biotin does not interfere. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Siemens mailed an Urgent Medical Device Correction Letter to affected customers on 03/29/2017 to inform them of the issue. The notice explained the reason for the field action, Risk to Health and actions to be taken by the customer. |
Quantity in Commerce | 70,428 units |
Distribution | Product was distributed throughout the United States and Canada, United Arab Emirates, Argentina, Austria,Australia,Bangladesh,Belgium,Brazil,Canada
Switzerland,China,Columbia,Czech Republic,Germany,Denmark,Algeria
Egypt,Spain,Finland,France,Great Britain,Greece,Croatia,Indonesia,Ireland
India,Italy,Japan,Canary Islands,Republic of Korea,Kuwait,Lebanon,Latvia
Macedonia,Netherlands,Norway,New Zealand,Philippines,Poland,Portugal
Qatar,Saudi Arabia,Slovenia,Slovakia,Turkey,Taiwan,South Africa |
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 = MMI
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