| 2026-06-12 |
Class II
|
Ongoing |
Z-2746-2026 |
ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in human serum o… |
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The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could ca… |
| 2020-08-07 |
Class II
|
Terminated |
Z-2968-2020 |
Tosoh Bioscience AIA-PACK BHCG Calibration Verification Test Set-In Vitro Diagnostic for BHCG-pregnancy Part number: 02… |
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Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%… |
| 2020-08-07 |
Class II
|
Terminated |
Z-2967-2020 |
Tosoh Bioscience AIA- PACK HCG Calibrator Set-In Vitro Diagnostic for BHCG Part number 020361 The AIA-Pack BHCG Cali… |
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Decreased stability for five (5) lots of Calibrator Sets and Calibration Verification Test Sets, resulting in a decrease measured concentration of HCG up to 20%… |
| 2020-05-22 |
Class II
|
Terminated |
Z-2423-2020 |
AIA-900 Analyzer, Part no. 022930, UDI 04560189283992 |
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The Substrate Monitoring System in the AIA-900 Analyzer did not detect an empty substrate bottle. The issue may lead to erroneous immunoassay test results. |
| 2020-01-10 |
Class II
|
Terminated |
Z-1420-2020 |
AIA-360 Automated Immunoassay Analyzer, Product Code 019945 |
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A display screen software issue on the analyzer causes the display to freeze when display screen is touched at the same time as a command from the instrument fi… |