Multichem P, Part Code 08P90-10

FDA device recall Z-0106-2024 · posted 2023-10-12 · Open, Classified

Recall details

Recalling firm

TECHNO-PATH MANUFACTURING LTD.

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.

Action taken

LGC Group notified their sole US consignee (distribution partner) of the recall on 08/25/2023 via email. The notice explained the issue and the risk with the request to notify their end users. The end user was advised to take additional care when handling the glass vials due to the potential of breakages upon receipt, while thawing, or while opening the vials.

Root cause

Unknown/Undetermined by firm

Status

Open, Classified

Product code

JJY

Quantity affected

2964 units

Distribution

US Nationwide distribution in the state of Illinois.

Date initiated

2023-08-25

Date posted

2023-10-12

Location

Ballina Tipperary, Ireland