Reported Oct 18, 2023 · Ongoing
Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
Techno-Path Manufacturing Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TECHNO-PATH MANUFACTURING LTD. · Fort Henry Business Park · Ballina Tipperary, N/A · N/A
Is this the product you have?
- Multichem S Plus
- Part Codes
a) 08P88-10b) 08P88-11c) 08P88-12
- Lot codes and dates
3 of 3 products
Products covered by this recall # Barcodes Product as published 1 0539152344077608P88-10, UDI/DI 05391523440776, Lot Numbers: 108032101, 110072101, 119112101, 126052201, 130112201, 131112201 2 0539152344078308P88-11, UDI/DI 05391523440783, Lot Numbers: 108032102, 110072102, 119112102, 126052202, 130112202, 131112202 3 0539152344079008P88-12, UDI/DI 05391523440790, Lot Numbers: 108032103, 110072103, 119112103, 126052203, 130112203, 131112203 - Amount recalled
- 117155 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- IL
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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