| Class 2 Device Recall The Dimension FT4L Flex reagent cartridge | |
Date Initiated by Firm | April 12, 2010 |
Date Posted | November 24, 2010 |
Recall Status1 |
Terminated 3 on March 19, 2013 |
Recall Number | Z-0458-2011 |
Recall Event ID |
55604 |
510(K)Number | K073604 |
Product Classification |
Radioimmunoassay, free thyroxine - Product Code CEC
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Product | The Dimension FT4L Flex reagent cartridge( Free Thyroxine) manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE. |
Code Information |
Lot# EC0122 Exp# 05/22/2010, Lot# EG0173, EXP# 06/22/2010, Lot# FA0219, EXP# 08/07/2010, Lot# FA0249, EXP# 09/06/2010, Lot# FB02626, EXP# 09/19/2010. |
Recalling Firm/ Manufacturer |
Siemens Healthcare Diagnostics, Inc. 500 GBC Drive, Mailstop 514 PO BOX 6101 Newark DE 19714-6101
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For Additional Information Contact | Technical Solutions 800-441-9250 |
Manufacturer Reason for Recall | Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaking cartridges may result in inaccurate test results. |
FDA Determined Cause 2 | Other |
Action | Siemens issued an "Urgent Field Safety Notice" dated April 2010, informing users of the problem and instructing them to inspect cartridges for leaking fluid. Cartridges with leaking fluid should be reported to the Siemens Technical Solutions Center. The Technical Solutions Center can be contacted at 800 441 9250. |
Quantity in Commerce | 1520 |
Distribution | Worldwide Distribution: USA, Europe, Australia, China, Japan, Korea, and Saudi Arabia. |
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 = CEC
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