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U.S. Department of Health and Human Services

Class 2 Device Recall Siemens IMMULITE 2000/ IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI)

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  Class 2 Device Recall Siemens IMMULITE 2000/ IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) see related information
Date Initiated by Firm August 11, 2022
Date Posted September 27, 2022
Recall Status1 Open3, Classified
Recall Number Z-1820-2022
Recall Event ID 90812
510(K)Number K152061  
Product Classification System, test, thyroid autoantibody - Product Code JZO
Product IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI)
Siemens Material Number (SMN): 10876421 US; 10713448 (OUS)
Code Information UDI-DI: (01)00630414597188(10)D389S(17)221130 (US); (01)00630414597171(10)389(17)221130 (OUS) Lot Number: 389 Exp.Date: 2022-11-30
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
333 Coney St
East Walpole MA 02032-1516
For Additional Information Contact SAME
508-668-5000
Manufacturer Reason
for Recall		 An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results. This may lead to a delayed follow up of patients with clinical autoimmune thyroid
FDA Determined
Cause 2		 Under Investigation by firm
Action Siemens Healthcare issued an "Urgent Medical Device Correction (UMDC IMC 22-09.A.US)" to US customers, and an "Urgent Field Safety Notice (UFSN IMC 22-09.A.OUS)" to Outside the US (OUS) customers. The UMDC and UFSN letters provide instructions to customers to follow: When this issue occurs, there is a potential for erroneously depressed patient results. This may lead to a delayed follow up of patients with clinical autoimmune thyroid. Mitigations would include correlation of tests results with additional tests such as anti-TPO antibodies along with thyroid function tests such as total T3 and T4, free T3 and T4 and TSH results. A review of previously generated results is not recommended as results would not be used in isolation. Actions to be Taken by the Customer: Please review this letter with your Medical Director. Discontinue use of and discard the Kit Lot listed in Table 1. Review your inventory of this product to determine your laboratory's replacement needs and to provide information to Siemens for reporting to the authorities. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days via email to: uscctsfcaecfax.team@siemens-healthineers.com Or to fax this completed form to the Customer Care Center at: (312) 275-7795 If you have received any complaints of illness or adverse events associated with the products listed in Table 1, immediately contact your local Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative. Please retain this letter with your laboratory records and forward this letter to those who may have received this product. If you have any questions, contact your local Siemens Healthineers technical support representative or call 508-668-5000.
Quantity in Commerce 100 units US; 328 units OUS
Distribution Worldwide Distribution: US (nationwide) to states of: FL IN MA MI NH NJ NY OH TX UT and OUS (Foreign) countries of: Australia¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿ Brazil¿¿¿¿¿¿¿¿¿ Czech¿Republic¿ Germany¿¿¿¿¿¿¿¿ Italy¿¿¿¿¿¿¿¿¿¿ P.R.¿China¿¿¿¿¿ Singapore¿¿¿¿¿¿ Spain¿¿¿¿¿¿¿¿¿¿ Taiwan¿¿¿¿¿¿¿¿¿ Tunisia¿¿¿¿¿¿¿¿ Turkey¿¿¿¿¿¿¿¿¿
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 = JZO and Original Applicant = SIEMENS HEALTHCARE DIAGNOSTICS, INC.
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