CLASS II ONGOING Device recall · Reported 18 Oct 2023 · FDA Enforcement Report
Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88 recalled
Techno-path Manufacturing is recalling Multichem S Plus, Part, distributed nationwide in the US. The recall was initiated on 25 Aug 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0104-2024
- FDA event ID
- 93017
- Recalling firm
- Techno-path Manufacturing, Ballina Tipperary, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 25 Aug 2023
- FDA classified
- 12 Oct 2023
- Reported
- 18 Oct 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Other Medical Devices
Timeline
| 25 Aug 2023 | Recall initiated by company | |
| 12 Oct 2023 | Classified by FDA | +48 days |
| 18 Oct 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
Where it was distributed
US Nationwide distribution in the state of Illinois.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
a) 08P88-10, UDI/DI 05391523440776, Lot Numbers: 108032101, 110072101, 119112101, 126052201, 130112201, 131112201; b) 08P88-11, UDI/DI 05391523440783, Lot Numbers: 108032102, 110072102, 119112102, 126052202, 130112202, 131112202; c) 08P88-12, UDI/DI 05391523440790, Lot Numbers: 108032103, 110072103, 119112103, 126052203, 130112203, 131112203
Where was it sold?
US Nationwide distribution in the state of Illinois.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 93017This product is part of a recall event; the main page for the event is Multichem P, Part recalled by Techno-path Manufacturing.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Multichem P, Part recalled by Techno-path Manufacturing | Techno-path Manufacturing | Foreign Material | Nationwide | |
| CLASS II | Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86 recalled | Techno-path Manufacturing | Foreign Material | Nationwide |
More recalls from Techno-path Manufacturing
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Multichem ID recalled by Techno-path Manufacturing | Techno-path Manufacturing | Potency & Assay | 17 states |
| Device | CLASS II | Multichem ID recalled by Techno-path Manufacturing | Techno-path Manufacturing | Potency & Assay | 17 states |
| Device | CLASS II | Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86 recalled | Techno-path Manufacturing | Foreign Material | Nationwide |
| Device | CLASS II | Multichem P, Part recalled by Techno-path Manufacturing | Techno-path Manufacturing | Foreign Material | Nationwide |
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