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U.S. Department of Health and Human Services

Class 2 Device Recall ADVIA Centaur TSH3Ultra

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  Class 2 Device Recall ADVIA Centaur TSH3Ultra see related information
Date Initiated by Firm December 18, 2017
Create Date June 01, 2018
Recall Status1 Open3, Classified
Recall Number Z-2054-2018
Recall Event ID 79496
510(K)Number K150403  
Product Classification Radioimmunoassay, thyroid-stimulating hormone - Product Code JLW
Product ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)
Code Information Lot Numbers ending in: 298 and 301
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
511 Benedict Ave
Tarrytown NY 10591-5005
For Additional Information Contact Ranjan Sadarangani
914-524-2868
Manufacturer Reason
for Recall		 In certain scenarios the ADVIA Centaur CP, XP and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays.
FDA Determined
Cause 2		 Device Design
Action Consignees are asked to return the response form and follow the instructions pertaining to their system and assays: Actions for ALL ADVIA Centaur Systems: Do not perform onboard dilutions on any ADVIA Centaur system if any of the affected kits are present on the system. Onboard dilutions for the ADVIA Centaur BNP and/or TSH3UL assay(s) are only supported when using ADVIA Centaur BNP kit lots ending in 210 and above and ADVIA Centaur TSH3UL kit lots ending in 310 and above. Actions for ADVIA Centaur XPT system: If you intend to perform onboard dilutions for the ADVIA Centaur BNP and/or TSH3UL assays, you must restart the workstation after scanning the master curve card for the BNP and/or TSH3UL assay kit lot, before ordering an onboard dilution for these assays. Please perform the attached steps to restart the workstation. Actions for ADVIA Centaur CP system: If any of the affected kit lots have been in use on the system, you must manually track the time that the Multi-Diluent 15 has been in use on board the system. Replace the ancillary pack of Multi-Diluent 15 every 7 days when used, until a follow-up communication is received from Siemens stating this issue has been resolved.
Quantity in Commerce 74,215
Distribution Distributed in the following U.S. states: AL, CA, DE, GA, IA, IL, IN, KY, MA, MI, MS, MT, NC, ND, NJ, NM, NV, NY, OH, PA, RI, TN, TX, VA, WA, WV, WY and Puerto Rico. Distributed in the following OUS countries: Australia Belgium¿¿¿¿¿¿¿¿ Canada Chile France¿¿¿¿¿¿¿¿¿ Germany¿¿¿¿¿¿¿¿ Greece¿¿¿¿¿¿¿¿¿ Israel Italy¿¿¿¿¿¿¿¿¿¿ Japan Latvia¿¿¿¿¿¿¿¿¿ Luxembourg¿¿¿¿¿ Netherlands¿¿¿¿ New Zealand Norway¿¿¿¿¿¿¿¿¿ Poland¿¿¿¿¿¿¿¿¿ Portugal¿¿¿¿¿¿¿ Romania¿¿¿¿¿¿¿¿ Singapore Slovakia¿¿¿¿¿¿¿ South Africa Spain¿¿¿¿¿¿¿¿¿¿ Switzerland¿¿¿¿ U.A.E.¿¿¿¿¿¿¿¿¿ United¿Kingdom¿
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JLW and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS, INC.
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