IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic Recalled by Siemens Healthcare Diagnostics, Inc. Due to Confirmed an average positive bias of 40% for...

Affected Products

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

About Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc. has 452 total recalls tracked by RecallDetector.

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