Recall Z-0207-2027— TECHNO-PATH MANUFACTURING LTD.
Class II · Ongoing
Class II FDA medical device recall by TECHNO-PATH MANUFACTURING LTD., initiated 2026-08-14. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- TECHNO-PATH MANUFACTURING LTD.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-08-14
- Firm location
- Ballina Tipperary, Ireland
Product description
Techno-Path Multichem AE Unassayed Level 3, REF:AE623X
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.