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U.S. Department of Health and Human Services

Class 2 Device Recall IMMULITE Total Testosterone Assay

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 Class 2 Device Recall IMMULITE Total Testosterone Assaysee related information
Date Initiated by FirmOctober 25, 2022
Date PostedDecember 02, 2022
Recall Status1 Open3, Classified
Recall NumberZ-0355-2023
Recall Event ID 91108
510(K)NumberK032881 
Product Classification Radioimmunoassay, testosterones and dihydrotestosterone - Product Code CDZ
ProductIMMULITE 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.
Code Information 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
FEI Number 1219913
Recalling Firm/
Manufacturer		 Siemens Healthcare Diagnostics, Inc.
333 Coney St
East Walpole MA 02032-1516
For Additional Information ContactSAME
508-668-5000
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		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 in Commerce867 units
DistributionWorldwide 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.¿¿¿¿
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = CDZ
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