CLASS II ONGOING Device recall · Reported 28 Oct 2026 · FDA Enforcement Report
Techno-Path Multichem AE Unassayed Level recalled
Techno-path Manufacturing is recalling Techno-Path Multichem AE Unassayed Level 2, distributed nationwide in the US. The recall was initiated on 14 Aug 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0206-2027
- FDA event ID
- 99724
- Recalling firm
- Techno-path Manufacturing, Ballina Tipperary
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Aug 2026
- FDA classified
- 22 Oct 2026
- Reported
- 28 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Device type
- Test Kits & Diagnostics
Timeline
| 14 Aug 2026 | Recall initiated by company | |
| 22 Oct 2026 | Classified by FDA | +69 days |
| 28 Oct 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Techno-Path Multichem AE Unassayed Level 2 REF: AE622X
Where it was distributed
US Nationwide distribution in the state of Massachusetts.
Questions about this recall
Why was it 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 points.
Which lots are affected?
UDI:(01)05391523442817/Lot # 65705262
Where was it sold?
US Nationwide distribution in the state of Massachusetts.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 3 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 99724| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Techno-Path Multichem AE Unassayed Level recalled | Techno-path Manufacturing | Potency & Assay | Nationwide | |
| CLASS II | Techno-Path Multichem AE Unassayed Level recalled | Techno-path Manufacturing | Potency & Assay | Nationwide |
More recalls from Techno-path Manufacturing
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Techno-Path Multichem AE Unassayed Level recalled | Techno-path Manufacturing | Potency & Assay | Nationwide |
| Device | CLASS II | Techno-Path Multichem AE Unassayed Level recalled | Techno-path Manufacturing | Potency & Assay | Nationwide |
| Device | CLASS II | Multichem ID recalled by Techno-path Manufacturing | Techno-path Manufacturing | Potency & Assay | 17 states |
| Device | CLASS II | Multichem ID recalled by Techno-path Manufacturing | Techno-path Manufacturing | Potency & Assay | 17 states |
| Device | CLASS II | Multichem IA Plus, Part Codes: a) 08P86-10, b) 08P86 recalled | Techno-path Manufacturing | Foreign Material | Nationwide |
Other Test Kits & Diagnostics recalls
All 2,671| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Techno-Path Multichem AE Unassayed Level recalled | Techno-path Manufacturing | Potency & Assay | Nationwide |
| Device | CLASS II | Techno-Path Multichem AE Unassayed Level recalled | Techno-path Manufacturing | Potency & Assay | Nationwide |
| Device | CLASS II | MAS Omni Immune PRO Liquid Assayed Integrated Immunoassay recalled | Microgenics | Potency & Assay | Nationwide |
| Device | CLASS II | The ABL90 Flex and ABL90 Flex Plus analyzers are intended recalled | Radiometer Medical ApS | Labeling Errors | Nationwide |
| Device | CLASS I | HemoslL AcuStar HIT-lgG(PF-4) recalled by Instrumentation Laboratory | Instrumentation Laboratory | Other | Nationwide |