- Recalling firm
- TECHNO-PATH MANUFACTURING LTD.
- 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.
- Affected products (lot / model / serial)
- UDI:(01)05391523442824/-Lot # 65705263
- Units affected
- 832 units
- Distribution pattern
- US Nationwide distribution in the state of Massachusetts.
- Firm location
- Ballina Tipperary, Ireland
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- E-Mail
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-0207-2027
- Recall initiated
- August 14, 2026
- FDA classification date
- October 22, 2026
- FDA report date
- October 28, 2026
- FDA event ID
- 99724
- Last updated on HTM Vibe
- November 3, 2026
