Techno-Path Multichem AE Unassayed Level 2 quality control material recalled for ammonia test instability
What this means
Stability testing found that ammonia measurements in certain lots of Techno-Path Multichem AE quality control material drift over time, making results unreliable. This affects only the ammonia test; other analytes are unaffected. Unreliable ammonia results could delay diagnosis of dangerously high ammonia levels in patient samples.
- Check if your laboratory received affected lots (Lot #65705262 or UDI 05391523442817).
- Stop using affected lots for ammonia quality control testing immediately.
- Contact Techno-Path Manufacturing for replacement material or further guidance.
- Review any ammonia test results issued using affected quality control lots.
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-0206-2027More Techno-Path Manufacturing recalls
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