Techno-Path Multichem AE Unassayed Level 3 recall (TECHNO-PATH MANUFACTURING LTD.)
Medical deviceClass IIOngoing
Summary: TECHNO-PATH MANUFACTURING LTD. is recalling Techno-Path Multichem AE Unassayed Level 3, REF:AE623X. Reason: 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 is being recalled
Techno-Path Multichem AE Unassayed Level 3, REF:AE623X
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the state of Massachusetts. (states named: Massachusetts)
How to tell if yours is affected
UDI:(01)05391523442824/-Lot # 65705263
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-0207-2027 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | August 14, 2026 |
| Reported | October 28, 2026 |
| Company | TECHNO-PATH MANUFACTURING LTD. |
| Company location | Ballina Tipperary, Ireland |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 832 units |
More recalls from TECHNO-PATH MANUFACTURING LTD. · all medical device recalls · recalls from August 2026