Recall Z-1078-2017— Sekisui Diagnostics P.E.I. Inc.

Name: FDA recall Z-1078-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-29

Class II · Terminated

Class II FDA medical device recall by Sekisui Diagnostics P.E.I. Inc., initiated 2016-11-29, terminated 2017-07-06. It names one FDA 510(k) clearance: K033921. Product: Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma. Reason: Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range..

Recalling firm: Sekisui Diagnostics P.E.I. Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-11-29
Terminated: 2017-07-06
Firm location: Charlottetown, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K033921 — AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10Diagnostic Chemicals , Ltd.·cleared 2004-03-10

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

Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma

Reason for recall

Certain lots are showing an atypical decrease in optical density (OD) over time, which may result in an impact to performance at the high end of the linear range.

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