Multichem control vials break during shipping or thawing due to glass defect
TECHNO-PATH MANUFACTURING LTD. is recalling Multichem S Plus and related control vials due to a defect in the glass vial commodity. The vials may break during delivery, thawing, or opening, potentially exposing users to biohazardous material and delaying patient results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—vials may break and potentially expose users to biohazardous material if cut, but no actual exposures or injuries have been reported, limiting the score to High per the rubric.
Plain-English summary
TECHNO-PATH MANUFACTURING LTD. is recalling 117,155 units of Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, Multichem IA Plus, and Multichem P Controls due to defective glass vials. The recalled products are distributed nationwide in the state of Illinois.
The manufacturer identified an issue with the glass vial commodity used to fill these products. The vials may break during delivery, while thawing, or while opening. Breakage can result in the bottom of the vial breaking off, breakage in the neck thread area, or cracking on the sides of the vial. Some customers have experienced broken vials when receiving or thawing the products.
If a vial breaks, the user may be exposed to biohazardous material if cut, and the breakage may cause a delay in patient results.
The recalled product
- Product
- Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
- Manufacturer
- TECHNO-PATH MANUFACTURING LTD.
- Hazard
- broken-glass
- biohazard-exposure
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- SevereMedtronic DLP Retrograde Cannula recalled for sterile barrier breach risk
FDA (Devices) · 2026-05-27
- HighAzurion X-ray System Deaeration Hose May Degrade and Cause Oil Leakage
FDA (Devices) · 2026-05-27
- HighSwan-Ganz Jr Catheter models recalled due to lumen hub leakage
FDA (Devices) · 2026-05-27
- SevereMedtronic DLP Retrograde Cannula Recalls for Sterile Barrier Breach Risk
FDA (Devices) · 2026-05-27
- HighMedtronic DLP Retrograde Cannula Cardiopulmonary Bypass Catheter Recall
FDA (Devices) · 2026-05-27