Recall Z-0355-2023 · CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
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.
| Date | Dec 2, 2022 (initiated Oct 25, 2022) |
| Status | Open, Classified |
| 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 temp |
| 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 |
| 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., |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032881 | IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE Diagnostic Products Corp., Oct 10, 2003 |