Class II U.S. Food and Drug Administration

Techno-Path Manufacturing Ltd. Techno-Path Multichem AE Unassayed Level 2 REF: AE622X recall: A routine stability studies have identified a stability drift affecting

Recall published 5 days ago

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.

The hazard: Device safety concern

This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0206-2027
Published
October 28, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Techno-Path Manufacturing Ltd.
Product type
Medical devices
Units affected
123 units
Distribution
Nationwide
Made in
Ireland
Lot / code info
UDI:(01)05391523442817/Lot # 65705262
UPC codes
05391523442817

Products covered by this recall

Techno-Path Multichem AE Unassayed Level 2 REF: AE622X

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 05391523442817

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 65705262

Model or item number

On the rating label, the box or the instruction sheet.

  • AE622X

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Techno-Path Manufacturing Ltd. — This is a device enforcement record. Check whether the remedy is a correction, a software update or a removal before changing anything.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. If you are a facility, quarantine affected stock and log the correction.
  3. Report device problems to the FDA through MedWatch.
  4. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.

Replacements, repairs and reimbursement

Device remedies run through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not face a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim rests on.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free, with return shipping paid.

Company contact: TECHNO-PATH MANUFACTURING LTD. — Fort Henry Business Park, Ballina Tipperary

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Techno-Path Manufacturing Ltd. medical devices recalled?

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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 05391523442817; lot code 65705262; model number AE622X. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Contact the distributor or clinic named on your paperwork and quote the recall number on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.

Where was the recalled product sold?

It was distributed nationwide.

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