United StatesWhat's being recalled
Techno-Path Multichem AE Unassayed Level 1 REF:AE621X
Techno-Path Multichem AE Unassayed Level 2 REF: AE622X
Techno-Path Multichem AE Unassayed Level 3, REF:AE623X
Recalling firm: Techno-Path Manufacturing LTD., Ballina Tipperary, Ireland.
How to identify it
UDI: (01)05391523442800/Lot # 65705261 UDI:(01)05391523442817/Lot # 65705262 UDI:(01)05391523442824/-Lot # 65705263
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide distribution in the state of Massachusetts.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)