Technopath recalls Multichem IA Plus units with specific part codes and lot numbers due to risk of broken glass vials exposing users to biohazardous material during handling or thawing.
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.
Technopath is recalling Multichem IA Plus devices with certain part codes and lot numbers because glass vials can break during delivery, thawing, or opening. Broken vials may expose users to biohazardous material or delay patient results.
Glass vials in the Multichem IA Plus can break during delivery, thawing, or opening. This breakage may cause the vial to crack, split, or break off, potentially exposing users to biohazardous material or delaying patient results.
Users of Multichem IA Plus devices with part codes 08P86-10 or 08P86-19 and specific lot numbers are most at risk. Healthcare professionals handling these devices during delivery, thawing, or opening may encounter broken vials.
Check for part codes 08P86-10 or 08P86-19 on the device. Look for specific lot numbers: 32004230, 35106210, 35810210, 36404220, 37209220 for part code 08P86-10 and 35506210, 36010210, 36604220, 37409220 for part code 08P86-19.
Identify part codes (08P86-10 or 08P86-19) and lot numbers to confirm if your device is affected.
The recall record states that glass vials can break during delivery, thawing, or opening, leading to potential exposure to biohazardous material.
The recall record does not specify actions for broken vials, only that they can cause exposure risks.
Check for part codes 08P86-10 or 08P86-19 and specific lot numbers listed in the recall notice.
We’ve drafted a message you can send Technopath to request your refund or repair — edit it as you like.
Subject: Recall Z-0105-2024 — Technopath Technopath Hello, I own a Technopath that is covered by recall Z-0105-2024 from Technopath. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
