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U.S. Department of Health and Human Services

Class 2 Device Recall IMMULITE/IMMULITE 1000 ThyroxineBinding Globulin

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 Class 2 Device Recall IMMULITE/IMMULITE 1000 ThyroxineBinding Globulinsee related information
Date Initiated by FirmApril 09, 2015
Date PostedMay 19, 2015
Recall Status1 Terminated 3 on March 22, 2017
Recall NumberZ-1629-2015
Recall Event ID 71006
510(K)NumberK950072 
Product Classification Radioimmunoassay, thyroxine-binding globulin - Product Code CEE
ProductIMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Globulin (TBG) in serum, as an aid in the diagnosis and treatment of thyroid diseases.
Code Information LOT 0257, SMN 10381643
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact
914-631-8000
Manufacturer Reason
for Recall		IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parameter of <1.80. The resulting slope of the kit is >1.80 resulting in the potential to produce depressed TBG patient values.
FDA Determined
Cause 2		Unknown/Undetermined by firm
ActionSiemens sent an Urgent Field Safety Notice dated April 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be Taken by the Customer Discontinue use and discard kit lot listed in Table 1. Review your inventory of these products to determine your laboratory's replacement needs. Please review this letter with your Medical Director. Complete and return the Field Correction Effectiveness Check Form attached to this letter within thirty (30) days. Please retain this letter with your laboratory records, and forward this letter to those who may have received this product. We apologize for the inconvenience this situation may cause. If you have any questions, please contact your Siemens Customer Care Center or your local Siemens technical support representative. For further questions call (914) 631-8000.
Quantity in Commerce155 kits
DistributionWorldwide Distribution to the countries of : Denmark, Spain, Great Britain, Germany, Bosnia Herzeg, China and Russian Federation.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = CEE
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