ELECSYS TESTOSTERONE II ASSAY · TESTOSTERONE ASSAY
ROCHE DIAGNOSTICS · Low Test Results, Output Problem +1
- Report to FDA
- N
- Manufacturer contact state
- IN
- Manufacturer link flag
- Y
- Manufacturer g1 city
- MANNHEIM (BADEN-WURTTEMBERG)
- Manufacturer contact address 1
- 9115 HAGUE ROAD
- Event type
- Malfunction
- Report number
- 1823260-2026-02854
- Product problem flag
- Y
- Date received
- 20260714
- PMA pmn number
- K211685
- Date of event
- 20260623
- Reprocessed and reused flag
- N
- Manufacturer contact zip code
- 46250
- Reporter occupation code
- OTHER HEALTH CARE PROFESSIONAL
- Noe summarized
- 1
- Manufacturer contact l name
- CATTON
- Manufacturer g1 postal code
- 68305
- Reporter country code
- US
- Date added
- 20260714
- Manufacturer contact f name
- NATALIE
- Previous use code
- N
- Suppl dates mfr received
- 07/22/2026
- Mfr report type
- Thirty-Day
- Manufacturer contact country
- US
- Date changed
- 20260908
- Health professional
- N
- Summary report flag
- N
- Date report
- 20260807
- Initial report to FDA
- No
- Manufacturer g1 country
- GM
- Manufacturer contact city
- INDIANAPOLIS
- MDR report key
- 25816716
- Date manufacturer received
- 20260623
- Report source code
- Manufacturer report
- Manufacturer g1 zip code
- 68305
- Manufacturer g1 name
- ROCHE DIAGNOSTICS GMBH
- Adverse event flag
- N
- Single use flag
- N
- Manufacturer g1 address 1
- SANDHOFER STRASSE 116
- Manufacturer contact postal code
- 46250
- Suppl dates FDA received
- 08/07/2026
- Type of report
- Initial submission, Followup
- Source type
- Foreign, Health Professional, User facility
- Device
- Device sequence number
- 470592
- Serviced by 3rd party flag
- N
- Date received
- 20260714
- Brand name
- ELECSYS TESTOSTERONE II ASSAY
- Generic name
- TESTOSTERONE ASSAY
- Manufacturer d name
- ROCHE DIAGNOSTICS
- Manufacturer d address 1
- 9115 HAGUE ROAD
- Manufacturer d city
- INDIANAPOLIS
- Manufacturer d state
- IN
- Manufacturer d zip code
- 46250
- Manufacturer d zip code ext
- 0457
- Manufacturer d country
- US
- Manufacturer d postal code
- 462500457
- Device operator
- HEALTH PROFESSIONAL
- Model number
- TESTOSTERONE
- Catalog number
- 08946370190
- Lot number
- 931457
- Device availability
- Yes
- Device report product code
- CDZ
- Device evaluated by manufacturer
- Y
- Combination product flag
- N
- Harmonized identifiers (openFDA)
- Device name
- Radioimmunoassay, Testosterones And Dihydrotestosterone
- Medical specialty description
- Clinical Chemistry
- Regulation number
- 862.1680
- Device class
- 1
- Product problems
- Low Test Results, Output Problem, Non Reproducible Results
- Patient
- Patient sequence number
- 1
- Date received
- 20260714
- Patient sex
- Unknown
- Patient problems
- No Clinical Signs, Symptoms or Conditions