TECHNO-PATH MANUFACTURING LTD. Recall 93017
Description: Multichem P, Part Code 08P90-10
TECHNO-PATH MANUFACTURING LTD. Recall 93017 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0106-2024 |
| Event ID | 93017 |
| Event Description | Multichem P, Part Code 08P90-10 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of Illinois. |
| Quantity | 2964 units |
| Recall Reason | 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, Multichem S Plus Level 3, Multichem IA Plus and Multichem P Controls. Some customers have experienced broken vials when receiving or thawing Technopath Multichem IA Plus and Multichem S Plus Controls. Breakages have been observed upon delivery, while thawing or while opening the vial. The breakages can result in the bottom of the vial breaking off, breakage in the neck thread area or cracking on the sides of the vial. This may expose the user to biohazardous material if cut and may cause a delay in patient results. |
| Device Classification | 20231018 |
| Device Code Info | UDI/DI 05391523440769, Lot Numbers: 04530621P, 04561021P, 04610523P |
| Center Classification Date | 20231012 |
| Recall Initiation Date | 20230825 |
| Recalling Firm | TECHNO-PATH MANUFACTURING LTD. |
| Initial Notification | |
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