RANDOX LABORATORIES, LTD. recalls AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
- Recall date
- July 30, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2966-2020
- FDA classification
- Class II
- Brand / firm
- RANDOX LABORATORIES, LTD.
- Sold / distributed
- US Distribution to states of: VA, UT, WV and country of : Canada
Why it was recalled
Randox Ammonia reagents are being recalled from the field due to a positive bias of up to 140¿mol/l being observed on patient samples.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Get recall alerts
Free email alert whenever RANDOX LABORATORIES, LTD. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: RANDOX LABORATORIES, LTD.