The Recall Desk
HighFDA (Devices)·Z-0105-2024·Announced 2023-10-18

Multichem IA Plus and Controls Recalled Due to Broken Glass Vials

TECHNO-PATH MANUFACTURING LTD. is recalling Multichem IA Plus and related controls due to broken glass vials that may expose laboratory personnel to biohazardous material. Affected lots should be discontinued immediately.

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 recall involving broken glass vials documented to be occurring in the field, creating a documented risk of exposure to biohazardous material and laceration to laboratory personnel. No injuries or illnesses have been reported in the source text, meeting the High severity criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Multichem IA Plus and Multichem S Plus Controls (Levels 1, 2, and 3), manufactured by TECHNO-PATH MANUFACTURING LTD., are being recalled. The recall affects 41,455 units. The affected part codes are 08P86-10 and 08P86-19, with specific lot numbers identified for each.

The glass vials used in these quality control reagents have been breaking during receipt, thawing, or opening. Breakage patterns include the bottom breaking off, fractures in the neck thread area, and cracks on the sides of the vial. If a vial breaks, laboratory personnel may be exposed to biohazardous material and risk cuts from sharp glass fragments.

The broken vials can delay patient test results and compromise laboratory safety operations. The FDA has classified this as a Class II recall.

Customers who have received affected lots should discontinue use immediately. Contact TECHNO-PATH MANUFACTURING LTD. for replacement vials. Check your product lot numbers and part codes against the recall notice to determine if your inventory is affected.

The recalled product

Product
Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86-19
Manufacturer
TECHNO-PATH MANUFACTURING LTD.
Category
Medical Device — Laboratory Quality Control Reagent
Hazard
Affected units
41,455

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 (13)

  • 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

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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