Summary
The FDA issued a Class II for Techno-Path Multichem AE Unassayed Level 3, REF:AE623X by TECHNO-PATH MANUFACTURING LTD.. Reason: A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control ma.
Details
Source
Device Recall
External ID
Z-0207-2027
Action Date
2026-10-28
Status
Ongoing
Category
device
Product Description
Techno-Path Multichem AE Unassayed Level 3, REF:AE623X
Lot/Code Info: UDI:(01)05391523442824/-Lot # 65705263
Quantity Affected: 832 units
Reason for Recall
A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots. This issue is limited to the Ammonia analyte only. The impacted device may cause delay of issuing results to the physician. Delayed recognition and diagnosis of elevated levels may impact in timely treatment of life-threatening levels described within medical toxicity intervention decision points.
Distribution
US Nationwide distribution in the state of Massachusetts.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-14
Company
Ballina Tipperary
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 187 device recalls issued in the same week, part of 480 device-related FDA actions this month.
TECHNO-PATH MANUFACTURING LTD. has 9 FDA actions in our database, including 8 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 9 FDA actions in our database, including 8 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0207-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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