TemporaryFDAOngoing
Can cause harm that is usually temporary.
Techno-Path Multichem AE Unassayed Level 2 REF: AE622X
Check the device or its packaging for
UDI:(01)05391523442817/Lot # 65705262
- 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.
- Distributed
- US Nationwide distribution in the state of Massachusetts.
- Company
- TECHNO-PATH MANUFACTURING LTD.
- Announced
- This is the date the recall was announced. A company may have started it weeks earlier.
- Recall began
Source: FDA record Z-0206-2027 · retrieved 22 October 2026
Read the official notice