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U.S. Department of Health and Human Services

Class 2 Device Recall IMMULITE 2000/IMMULITE 2000 XPi CEA

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  Class 2 Device Recall IMMULITE 2000/IMMULITE 2000 XPi CEA see related information
Date Initiated by Firm January 02, 2018
Date Posted May 04, 2018
Recall Status1 Terminated 3 on February 10, 2023
Recall Number Z-1679-2018
Recall Event ID 79505
510(K)Number K980855  
Product Classification System, test, carcinoembryonic antigen - Product Code DHX
Product IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA
Code Information CEA, CEA (IMMULITE/IMMULITE 1000, LKCE1), (IMMULITE 2000/IMMULITE 2000 XPi, LKCE2, LKCE6)  Lot codes: 0355 0356 0357  CEA Lot # 200 tests 311 312 313  
Recalling Firm/
Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact Ms. Aarti M. Aziz
Manufacturer Reason
for Recall
Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the following IMMULITE assays, 3gAllergy Specific IgE, anti-HBc, BR-MA (CA15-3), CEA, Folic Acid, Gastrin, OM-MA (CA125), Thyroglobulin, and Vitamin B12, and these assays are susceptible to interference from biotin.
FDA Determined
Cause 2
Error in labeling
Action Siemens Healthcare Diagnostics issued a recall in March 2017 for products with incorrect units for biotin in the Instructions for Use. After further investigation, recalling firm determined that more Siemens products also had missing or incorrect information in the IFUs for which two recalls were initiated, and Amended Corrections and Removals Reports were submitted to the FDA
Distribution Nationwide and Canada, Mexico, and Thailand
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = DHX and Original Applicant = DPC CIRRUS