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Medical Device

Techno-Path Multichem AE Unassayed Level 3, REF:AE623X

Recall date: 2026-10-28 · Source: FDA_DEVICE
Brand / Firm
TECHNO-PATH MANUFACTURING LTD.
Product
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.
Units affected
832 units
Description
Techno-Path Multichem AE Unassayed Level 3, REF:AE623X
View official recall notice →