Z-0104-2024Class II

Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12

Name: Z-0104-2024 Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
Creator: Techno-Path Manufacturing Ltd.
Published: 2023-08-25
License: https://open.fda.gov/license/

Techno-Path Manufacturing Ltd. / initiated 2023-08-25 / Open, Classified / root cause: manufacturing process

FDA source

TECHNO-PATH MANUFACTURING LTD. began a recall of Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12 on 2023-08-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0104-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-25
Posted: 2023-10-12
Recalling firm: Techno-Path Manufacturing Ltd.
Product: Multichem S Plus, Part Codes: a) 08P88-10, b) 08P88-11, c) 08P88-12
Product code: JJY Multi-Analyte Controls, All Kinds (Assayed)
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.
Root cause tag: manufacturing process
FDA root cause: Unknown/Undetermined by firm
Action: LGC Group notified their sole US consignee (distribution partner) of the recall on 08/25/2023 via email. The notice explained the issue and the risk with the request to notify their end users. The end user was advised to take additional care when handling the glass vials due to the potential of breakages upon receipt, while thawing, or while opening the vials.
Quantity in commerce: 117155 units
Distribution: US Nationwide distribution in the state of Illinois.
Product codes and lots: 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, 119112103, 126052203, 130112203, 131112203

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0104-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0104-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-12
Z-0105-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-12
Z-0106-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-18	2023-10-12

Product code JJY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)