TECHNO-PATH MANUFACTURING LTD.: Medical Device Recall in 2023 - (Recall #: Z-0105-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19

Product Classification:

Class II

Date Initiated: August 25, 2023

Date Posted: October 18, 2023

Recall Number: Z-0105-2024

Event ID: 93017

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.

Status: Ongoing

Product Quantity: 41455 units

Code Information:

a) 08P86-10, UDI/DI 05391523440745, Lot Numbers: 32004230, 35106210, 35810210, 36404220, 37209220; b) 08P86-19, UDI/DI 05391523441636, Lot Numbers: 35506210, 36010210, 36604220, 37409220

Distribution Pattern:

US Nationwide distribution in the state of Illinois.

Voluntary or Mandated:

Voluntary: Firm initiated