OVERLOOKED

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Class IIOngoing

TECHNO-PATH MANUFACTURING LTD. recalls 3 products

Recall date · record updated Oct 28, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
TECHNO-PATH MANUFACTURING LTD.
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.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution in the state of Massachusetts.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99724…

Products (3)

  1. Techno-Path Multichem AE Unassayed Level 1 REF:AE621X

    Codes/lots: UDI: (01)05391523442800/Lot # 65705261Quantity: 832 unitsRecall no. Z-0205-2027Class II

  2. Techno-Path Multichem AE Unassayed Level 2 REF: AE622X

    Codes/lots: UDI:(01)05391523442817/Lot # 65705262Quantity: 123 unitsRecall no. Z-0206-2027Class II

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

    Codes/lots: UDI:(01)05391523442824/-Lot # 65705263Quantity: 832 unitsRecall no. Z-0207-2027Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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