| 2025-10-17 |
Class II
|
Ongoing |
Z-0502-2026 |
Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to … |
— |
Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform. |
| 2025-10-17 |
Class II
|
Ongoing |
Z-0501-2026 |
Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control se… |
— |
Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform. |
| 2023-08-25 |
Class II
|
Ongoing |
Z-0106-2024 |
Multichem P, Part Code 08P90-10 |
— |
Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multich… |
| 2023-08-25 |
Class II
|
Ongoing |
Z-0105-2024 |
Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19 |
— |
Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multich… |
| 2023-08-25 |
Class II
|
Ongoing |
Z-0104-2024 |
Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12 |
— |
Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multich… |