FDA recall, , Moderate risk
Techno-Path Multichem AE Unassayed Chemistry Controls
Techno-Path Multichem AE quality control material has a stability drift affecting the Ammonia analyte, which may delay results to the physician.
Summary by Recall Canary from the FDA notice
What happened
Techno-Path Manufacturing Ltd. recalled Techno-Path Multichem AE Unassayed Level 1, Level 2, and Level 3 quality control material because routine stability studies identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots. Additional testing confirmed that the labelled shelf-life performance claim for the Ammonia analyte can no longer be supported for the affected lots, and the issue is limited to the Ammonia analyte only.
The recall began on August 14, 2026, and was added to the FDA's Enforcement Report on October 22, 2026. The products had distribution in the state of Massachusetts.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 products
Match the UDI-DI, lot code and reference number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Techno-Path Multichem AE Unassayed Level 1 REF:AE621X
- UDI-DI
- 05391523442800
- Lot code
- 65705261
Techno-Path Multichem AE Unassayed Level 3
- UDI-DI
- 05391523442824
- Reference number
- AE623X
- Lot code
- 65705263
Techno-Path Multichem AE Unassayed Level 2 REF: AE622X
- UDI-DI
- 05391523442817
- Lot code
- 65705262
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the state of Massachusetts.
- Company
- TECHNO-PATH MANUFACTURING LTD.
- Hazard
- Labeling error
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99724
- Recall numbers
- Z-0205-2027 to Z-0207-2027
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
