Recall Z-0164-2016— Sentinel CH SpA

Name: FDA recall Z-0164-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-22

Class II · Terminated

Class II FDA medical device recall by Sentinel CH SpA, initiated 2015-09-22, terminated 2016-03-30. It names one FDA 510(k) clearance: K051114. Product: Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.. Reason: Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes..

Recalling firm: Sentinel CH SpA
Classification: Class II
Status: Terminated
Initiated: 2015-09-22
Terminated: 2016-03-30
Firm location: Milano, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K051114 — SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAYSentinel Ch. Srl·cleared 2005-11-25

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

Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.

Reason for recall

Results for ammonia are below the linear range of the assay for samples that have been collected in sodium or lithium heparin tubes.

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