TECHNO-PATH MANUFACTURING LTD. recalls Techno-Path Multichem AE Unassayed Level 1 REF:AE621X
- Recalling company
- TECHNO-PATH MANUFACTURING LTD.
- Product
- Techno-Path Multichem AE Unassayed Level 1 REF:AE621X
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Aug 14, 2026
- Reported
- Oct 28, 2026
- Distribution
- US Nationwide distribution in the state of Massachusetts.
- Status
- Ongoing
- Quantity
- 832 units
- Lot / codes
- UDI: (01)05391523442800/Lot # 65705261
- Company location
- Ballina Tipperary
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0205-2027
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0205-2027 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.