Recall Z-2965-2020— RANDOX LABORATORIES, LTD.

Name: FDA recall Z-2965-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-30

Class II · Terminated

Class II FDA medical device recall by RANDOX LABORATORIES, LTD., initiated 2020-07-30, terminated 2021-02-03. It names one FDA 510(k) clearance: K030873. Product: AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasma. Reason: 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..

Recalling firm: RANDOX LABORATORIES, LTD.
Classification: Class II
Status: Terminated
Initiated: 2020-07-30
Terminated: 2021-02-03
Firm location: Crumlin Colorado Antrim, N/A, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K030873 — RANDOX AMMONIARandox Laboratories, Ltd.·cleared 2003-05-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.