Summary
The FDA issued a Class II for Multichem P, Part Code 08P90-10 by TECHNO-PATH MANUFACTURING LTD.. Reason: 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 .
Details
Source
Device Recall
External ID
Z-0106-2024
Action Date
2023-10-18
Status
Ongoing
Category
device
Product Description
Multichem P, Part Code 08P90-10
Lot/Code Info: UDI/DI 05391523440769, Lot Numbers: 04530621P, 04561021P, 04610523P
Quantity Affected: 2964 units
Reason for Recall
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.
Distribution
US Nationwide distribution in the state of Illinois.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-25
Company
Ballina Tipperary, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 179 device recalls issued in the same week, part of 403 device-related FDA actions this month.
TECHNO-PATH MANUFACTURING LTD. has 6 FDA actions in our database, including 5 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (TECHNO-PATH MANUFACTURING LTD.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does TECHNO-PATH MANUFACTURING LTD. have FDA actions?
TECHNO-PATH MANUFACTURING LTD. has 6 FDA actions in our database, including 5 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0106-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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