Reported Oct 28, 2026 · Ongoing
Techno-Path Multichem AE Unassayed Level 1 REF:AE621X
Techno-Path Manufacturing Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TECHNO-PATH MANUFACTURING LTD. · Fort Henry Business Park · Ballina Tipperary
Is this the product you have?
- Techno-Path
- Multichem AE Unassayed Level 1 REFAE621X
- Lot codes and dates
- UDI(01)05391523442800/Lot # 65705261
- Amount recalled
- 832 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- MA
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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