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Class 2 Device Recall Dimension Vista Homocysteine Flex Reagent Cartridge (HCYS) |
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Date Initiated by Firm |
May 17, 2016 |
Create Date |
July 19, 2016 |
Recall Status1 |
Terminated 3 on February 07, 2018 |
Recall Number |
Z-2241-2016 |
Recall Event ID |
74468 |
510(K)Number |
K063206
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Product Classification |
Urinary Homocystine (Nonquantitative) Test System - Product Code LPS
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Product |
Dimension Vista¿ Homocysteine Flex Reagent Cartridge (HCYS), Device Listing No.: D017878 is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and EDTA plasma on the Dimension Vista System. |
Code Information |
Lot Number 15243MA Mfg Date: 08/31/2015 Exp Date: 05/31/2016 Lot Number 15243MB Mfg Datge: 08/31/2015 Exp Date: 05/31/2016 |
Recalling Firm/ Manufacturer |
CSL Behring GmbH Emil-von-Behring-Str. 76 Marburg Germany
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For Additional Information Contact |
Richard Andersen 302-631-0528
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Manufacturer Reason for Recall |
Reagent lots # 15243MA and 15243MB shows a reduced stability once opened that does not meet the Instructions For Use claim of seven (7) days. A maximum bias of -37% was observed.
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Siemens mailed an Urgent Medical Device Recall to all customers who received the affected lots notifying them of the following: 1) Discontinue use and discard any remaining inventory of the affected lots, and 2) Indicate their replacement product needs within 30 days. |
Quantity in Commerce |
898 units |
Distribution |
Distributed to: AL, AR, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, UT, VA, WI, WV |
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 = LPS and Original Applicant = DADE BEHRING, INC.
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