The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0104-2024·Announced 2023-10-18

Multichem control vials break during shipping or thawing due to glass defect

TECHNO-PATH MANUFACTURING LTD. is recalling Multichem S Plus and related control vials due to a defect in the glass vial commodity. The vials may break during delivery, thawing, or opening, potentially exposing users to biohazardous material and delaying patient results.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 recall with no reported illnesses or injuries. The hazard is theoretical—vials may break and potentially expose users to biohazardous material if cut, but no actual exposures or injuries have been reported, limiting the score to High per the rubric.

Plain-English summary

TECHNO-PATH MANUFACTURING LTD. is recalling 117,155 units of Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, Multichem IA Plus, and Multichem P Controls due to defective glass vials. The recalled products are distributed nationwide in the state of Illinois.

The manufacturer identified an issue with the glass vial commodity used to fill these products. The vials may break during delivery, while thawing, or while opening. Breakage can result in the bottom of the vial breaking off, breakage in the neck thread area, or cracking on the sides of the vial. Some customers have experienced broken vials when receiving or thawing the products.

If a vial breaks, the user may be exposed to biohazardous material if cut, and the breakage may cause a delay in patient results.

The recalled product

Product
Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
Manufacturer
TECHNO-PATH MANUFACTURING LTD.
Category
Medical Device — Laboratory Control / Assay Control
Hazard
Affected units
117,155

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 (20)

  • a) 08P88-10
  • UDI/DI 05391523440776
  • Lot Numbers: 108032101
  • 110072101
  • 119112101
  • 126052201
  • 130112201
  • 131112201
  • b) 08P88-11
  • UDI/DI 05391523440783
  • Lot Numbers: 108032102
  • 110072102
  • 119112102
  • 126052202
  • 130112202
  • 131112202
  • c) 08P88-12
  • UDI/DI 05391523440790
  • Lot Numbers: 108032103
  • 110072103

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 →

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