—#195933

Product

IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US; 10713448 (OUS)

FDA product code: JZO — System, Test, Thyroid Autoantibody
Device class: Class 2
Medical specialty: Immunology
510(k) numbers: K152061
Affected lot / code info: UDI-DI: (01)00630414597188(10)D389S(17)221130 (US); (01)00630414597171(10)389(17)221130 (OUS) Lot Number: 389 Exp.Date: 2022-11-30

Why it was recalled

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

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Siemens Healthcare Diagnostics, Inc.
Address: 333 Coney St, East Walpole, Massachusetts 02032-1516

Distribution

Distribution pattern: 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¿¿¿¿¿¿¿¿¿

Timeline

Recall initiated: 2022-08-11
Posted by FDA: 2022-09-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #195933. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.