PlainRecalls
FDA Devices Moderate Class II Ongoing

Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12

Reported: October 18, 2023 Initiated: August 25, 2023 #Z-0104-2024

Product Description

Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12

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.

Details

Units Affected
117155 units
Distribution
US Nationwide distribution in the state of Illinois.
Location
Ballina Tipperary, N/A

Frequently Asked Questions

What product was recalled?
Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12. Recalled by TECHNO-PATH MANUFACTURING LTD.. Units affected: 117155 units.
Why was this product 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 agency issued this recall?
This recall was issued by the FDA Devices on October 18, 2023. Severity: Moderate. Recall number: Z-0104-2024.