AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Reported: September 23, 2020 Initiated: July 30, 2020 #Z-2965-2020
Product Description
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma
Reason for Recall
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.
Details
- Recalling Firm
- RANDOX LABORATORIES, LTD.
- Units Affected
- 143 kits in total
- Distribution
- US Distribution to states of: VA, UT, WV and country of : Canada
- Location
- Crumlin Colorado Antrim, N/A
Frequently Asked Questions
What product was recalled? ▼
AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma. Recalled by RANDOX LABORATORIES, LTD.. Units affected: 143 kits in total.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 23, 2020. Severity: Moderate. Recall number: Z-2965-2020.
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