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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91108

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
October 25, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Siemens Healthcare Diagnostics, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-0355-2023
Recall number
Z-0355-2023
Initiated
October 25, 2022
Classification
Class II
Status
Ongoing
Quantity
867 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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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.

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

Distribution pattern

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.¿¿¿¿