Techno-Path Multichem AE Level 3 quality control material recalled for ammonia analyte stability drift
What this means
Stability testing found that ammonia measurements in specific lots of Techno-Path Multichem AE Level 3 quality control material degrade faster than labeled. This affects only the ammonia analyte. Labs using affected lots may get delayed or inaccurate results, which could delay diagnosis of dangerously high ammonia levels.
- Check if your lab uses Multichem AE Level 3, REF:AE623X, Lot #65705263 or the affected UDI listed in the recall notice.
- If you have affected lot(s), stop using them and contact Techno-Path for replacement or guidance.
- Review any ammonia results issued from the affected lots and consider retesting patient samples if clinically indicated.
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-0207-2027More Techno-Path Manufacturing recalls
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