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IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating… recallZ-1820-2022 · Siemens Healthcare Diagnostics, Inc. · initiated Aug 11, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Siemens Healthcare Diagnostics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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

FDA root cause category: Under Investigation by firm

What the company is doing

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: [email protected] 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.

Recall details

Recall number
Z-1820-2022
Status
Open, Classified
Initiated by the company
Aug 11, 2022
Posted by the FDA
Sep 27, 2022
Recalling firm
Siemens Healthcare Diagnostics, Inc.
Quantity
100 units US; 328 units OUS
Product code
JZO
FDA submissions
K152061
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¿¿¿¿¿¿¿¿¿

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: (01)00630414597188(10)D389S(17)221130 (US); (01)00630414597171(10)389(17)221130 (OUS) Lot Number: 389 Exp.Date: 2022-11-30

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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