Device recall
Techno-Path Multichem AE Unassayed Level 1 REF:AE621X
- Recall number
- Z-0205-2027
- Event id
- 99724
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- TECHNO-PATH MANUFACTURING LTD.
- Report date
- Oct 28, 2026
- Posted
- Oct 22, 2026
- Initiated
- Aug 14, 2026
- Center classification date
- Oct 22, 2026
- Product code
- OHQ
- Device type
- Multi-Analyte Controls Unassayed
- 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.
- Root cause
- Under Investigation by firm
- Quantity
- 832 units
- Code info
- UDI: (01)05391523442800/Lot # 65705261
- Distribution
- US Nationwide distribution in the state of Massachusetts.
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Ballina Tipperary, Ireland