Siemens Healthcare Diagnostics, Inc.: IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of total testosterone in serum and heparinized plasma.

Recall number

Z-0355-2023

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Product

IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of total testosterone in serum and heparinized plasma.

Status

Open, Classified

Initiated

2022-10-25

Posted

2022-12-02

Terminated

not on file

Reason

Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9 nmol/L) and above with the IMMULITE/IMMULITE 1000 Total Testosterone Assay when compared to the IMMULITE 2000/IMMULITE 2000 XPi Total Testosterone Assay. Two (2) lots of Total Testosterone assays for the IMMULITE/IMMULITE 1000, kit lots #515 and #516 were actively distributed to customers when the issue was discovered by Siemens, and they are subject to the correction or removal in this recall (867 total quantity of reagents distributed for each lot). The violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. In both males and female, testosterone results are not used in isolation but are interpreted in conjunction with clinical history and symptomology as well as with other laboratory testing (e.g. gonadotropins and other sex steroids). A delay in the diagnosis may be experienced and medical intervention, such as repeat testing may be required.

Root cause

Process control

Action

Siemens has issued an "Urgent Medical Device Correction (UMDC)" IMC 23-02.A.US to US customers via FedEx beginning on 10/25/2022. An Urgent Field Safety Notice (UFSN) IMC 23-02.A.OUS to Outside the US (OUS) customers for distribution and regional reporting to their local competent authorities beginning on 10/25/2022. Letters states reason for recall, health risk and action to take: Please review this letter with your Medical Director. You may continue use of the IMMULITE/IMMULITE 1000 Total Testosterone Assay kit lots listed in Table 1 to report values below 660 ng/dL (22.9 nmol/L) until you receive replacement product in your laboratory. Refer to Figures 1 and 2 for IMMULITE/IMMULITE 1000 Total Testosterone bias information. If you are currently using IMMULITE/IMMULITE 1000 Total Testosterone Assay kit lots listed in Table 1, review your inventory needs of these products, and order replacement products by completing the Field Correction Effectiveness Check Form attached to this letter. Upon acceptance of the re-aligned replacement lots, discontinue use of and discard the products listed in Table 1. Refer to Figures 3 - 6 for expected results with replacement lots. Complete and return the Field Correction Effectiveness Check Form attached to this letter within 30 days. 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, please contact your Siemens Healthineers Customer Care Center or your local Siemens Healthineers technical support representative.

Quantity

867 units

Distribution

Worldwide Distribution: US (nationwide) to states of: AL, CA, FL, GA, IN, KY, NC, NE, OR, SD, TX, UT; and OUS (Foreign) to countries of: Canada, Mexico, Austria, Argentina, Austria, Bangladesh, Colombia, Brazil, Bulgaria, Costa¿Rica, Cyprus, Estonia, Germany, Greece, India, U.A.E., Italy, Kazakhstan, Latvia, P.R.¿China, Romania, Russian¿Fed., South Africa, Spain, United Kingdom, Uruguay and Singapore.¿¿¿¿

Lot, serial or model codes

UDI: (01)00630414964782(10)0515(17)20221130; (01)00630414964782(10)0516(17)20221231 Lot Numbers: 515, Exp Date: 2022-11-30 516, Exp Date: 2022-12-31

510(k) numbers

K032881

PMA numbers

not on file

Product code

CDZ

Firm FEI

1219913

Firm city

East Walpole

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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