Official recall record
Techno-Path Multichem AE Unassayed Level 2 REF: AE622X
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2026-08-14
- Country of alert
- Ireland
- Alert level
- Class II
- Alert type
- recall
- Barcode (EAN/GTIN)
- 05391523442817
- Brand on record
- TECHNO-PATH MANUFACTURING LTD.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-11-13.
Other recalls from this brand
- 2026-08-14 · US FDA — Medical Devices
Techno-Path Multichem AE Unassayed Level 1 REF:AE621X - 2026-08-14 · US FDA — Medical Devices
Techno-Path Multichem AE Unassayed Level 3, REF:AE623X - 2023-08-25 · US FDA — Medical Devices
Multichem P, Part Code 08P90-10
All 5 official recall notices naming TECHNO-PATH MANUFACTURING LTD. on this site →