The Recall Desk
HighFDA (Devices)·Z-0106-2024·Announced 2023-10-18

Glass Vials in Laboratory Control Products Recalled for Breakage Risk

Multichem P and related laboratory control products are recalled due to defective glass vials that may break during delivery or use, potentially exposing users to biohazardous material.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with risk-of-harm from broken glass and biohazard exposure, but no reported illnesses or injuries. Meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

TECHNO-PATH MANUFACTURING LTD. has recalled Multichem P (Part Code 08P90-10) and related laboratory control products due to defective glass vials. The recalled products include Multichem S Plus Level 1, Level 2, Level 3, Multichem IA Plus, and Multichem P Controls. The recall affects 2,964 units with lot numbers 04530621P, 04561021P, and 04610523P.

The glass vials used to fill these control products are defective and prone to breaking. Vials may break during delivery, while thawing, or when being opened, with breakages occurring at the bottom of the vial, the neck thread area, or the sides.

Broken vials may expose users to biohazardous material and cause cuts if contacted. Broken vials may also delay patient test results. Customers who have received affected products should inspect them for damage and handle broken or cracked vials carefully. Contact TECHNO-PATH MANUFACTURING LTD. for instructions on replacement or proper disposal.

The recalled product

Product
Multichem P, Part Code 08P90-10
Manufacturer
TECHNO-PATH MANUFACTURING LTD.
Category
Medical Device — Laboratory Controls
Hazard
Affected units
2,964

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • UDI/DI 05391523440769
  • Lot Numbers: 04530621P
  • 04561021P
  • 04610523P

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by TECHNO-PATH MANUFACTURING LTD. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · TECHNO-PATH MANUFACTURING LTD.

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Same hazard · broken glass

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