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U.S. Department of Health and Human Services

Class 2 Device Recall IMMULITE 2000/IMMULITE 2000 XPi Folic Acid

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 Class 2 Device Recall IMMULITE 2000/IMMULITE 2000 XPi Folic Acidsee related information
Date Initiated by FirmJanuary 02, 2018
Date PostedMay 04, 2018
Recall Status1 Terminated 3 on February 10, 2023
Recall NumberZ-1676-2018
Recall Event ID 79505
510(K)NumberK993254 
Product Classification Acid, folic, radioimmunoassay - Product Code CGN
ProductIMMULITE 2000/IMMULITE 2000 XPi Folic Acid
Code Information Folic Acid, Folic Acid (IMMULITE 2000/IMMULITE 2000 XPi L2KFO2, L2KFO6)  Lot codes: Folic Acid Lot # 502 503 504 505 506 508 514 
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information ContactMs. Aarti M. Aziz
914-631-8000
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
ActionSiemens 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
DistributionNationwide and Canada, Mexico, and Thailand
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 = CGN
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