# Class II recall Z-0206-2027: TECHNO-PATH MANUFACTURING LTD.

**Predicate Speed & CAPA Advisory Opportunity Score:** 68/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0206-2027 |
| Recalling firm | TECHNO-PATH MANUFACTURING LTD. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | Techno-Path Multichem AE Unassayed Level 2  REF: AE622X |
| 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. |
| Quantity | 123 units |
| Distribution | US Nationwide distribution in the state of Massachusetts. |
| Recall initiated | 2026-08-14 |
| Reported | 2026-10-28 |
| Firm location | Ballina Tipperary, Ireland |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 8 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0206-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.