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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

TECHNO-PATH MANUFACTURING LTD.: Laboratory Control Vials Recalled Due to Risk of Glass Breakage

Agency Publication Date: October 12, 2023
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Summary

Techno-Path Manufacturing Ltd. has recalled approximately 161,574 units of Multichem laboratory control products because the glass vials used to hold the material may crack or break. Reports indicate that these vials can break during delivery, while being thawed for use, or while being opened by laboratory staff. The breakage often occurs at the bottom of the vial, near the neck threads, or as cracks along the sides. If you use these products, contact your healthcare provider or the manufacturer for further instructions and a potential refund.

Risk

Broken or cracked vials may expose users to biohazardous materials through cuts or skin contact. Additionally, damaged vials can lead to a delay in patient test results if the control material is compromised or unavailable for laboratory calibration.

What You Should Do

  1. Identify your product by checking the Part Codes and Lot Numbers on the packaging for Multichem S Plus (Part Codes 08P88-10, 08P88-11, 08P88-12), Multichem IA Plus (Part Codes 08P86-10, 08P86-19), and Multichem P (Part Code 08P90-10).
  2. If you have Multichem S Plus Part 08P88-10, check for Lot Numbers: 108032101, 110072101, 119112101, 126052201, 130112201, or 131112201.
  3. If you have Multichem S Plus Part 08P88-11, check for Lot Numbers: 108032102, 110072102, 119112102, 126052202, 130112202, or 131112202.
  4. If you have Multichem S Plus Part 08P88-12, check for Lot Numbers: 108032103, 110072103, 119112103, 126052203, 130112203, or 131112203.
  5. If you have Multichem IA Plus Part 08P86-10, check for Lot Numbers: 32004230, 35106210, 35810210, 36404220, or 37209220; for Part 08P86-19, check for Lot Numbers: 35506210, 36010210, 36604220, or 37409220.
  6. If you have Multichem P Part 08P90-10, check for Lot Numbers: 04530621P, 04561021P, or 04610523P.
  7. Exercise extreme caution when handling these vials, especially during thawing or opening, to avoid injury from glass fragments or exposure to biohazardous contents.
  8. Contact Technopath Manufacturing Ltd. or your healthcare provider to report affected stock and receive instructions on replacement or disposal.
  9. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Contact the manufacturer or healthcare provider for instructions.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Multichem S Plus Level 1, 2, and 3
Model / REF:
08P88-10
08P88-11
08P88-12
UPC Codes:
05391523440776
05391523440783
05391523440790
Lot Numbers:
108032101
110072101
119112101
126052201
130112201
131112201
108032102
110072102
119112102
126052202
130112202
131112202
108032103
110072103
119112103
126052203
130112203
131112203
Product: Multichem IA Plus
Model / REF:
08P86-10
08P86-19
UPC Codes:
05391523440745
05391523441636
Lot Numbers:
32004230
35106210
35810210
36404220
37209220
35506210
36010210
36604220
37409220
Product: Multichem P
Model / REF:
08P90-10
UPC Codes:
05391523440769
Lot Numbers:
04530621P
04561021P
04610523P

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93017
Status: Active
Manufacturer: TECHNO-PATH MANUFACTURING LTD.
Sold By: Specialty medical distributors
Manufactured In: Ireland
Units Affected: 3 products (117155 units; 41455 units; 2964 units)
Distributed To: Illinois

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.