Techno-Path Multichem AE Unassayed Level 1 quality control material recalled for ammonia measurement stability drift
What this means
Stability testing found that ammonia (NH4+) measurements in specific lots of this quality control material drift over time, making the labeled shelf-life claim unreliable. Labs using affected lots may get delayed or inaccurate results, which could delay diagnosis of dangerously high ammonia levels that need urgent treatment.
- Check if your lab has any Multichem AE Unassayed Level 1 material with Lot #65705261 or UDI (01)05391523442800.
- If you have affected lots, discontinue use and contact Techno-Path Manufacturing for a replacement or refund.
- Review any recent ammonia test results from affected lots with your lab director to assess impact on patient reports.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0205-2027More Techno-Path Manufacturing recalls
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