Z-1078-2017Class II

Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative...

Name: Z-1078-2017 Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative...
Creator: Sekisui Diagnostics P.E.I. Inc.
Published: 2016-11-29
License: https://open.fda.gov/license/

Sekisui Diagnostics P.E.I. Inc. / initiated 2016-11-29 / Terminated / root cause: manufacturing process

FDA source

Sekisui Diagnostics P.E.I. Inc. began a recall of Sekisui Diagnostics Ammonia L3K Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasma on 2016-11-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1078-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-29
Posted: 2017-01-23
Terminated: 2017-07-06
Recalling firm: Sekisui Diagnostics P.E.I. Inc.
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
Product code: JIF Enzymatic Method, Ammonia
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.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Sekisui Diagnostics sent an Important Product Correction Notification letter dated November 29, 2016, to all affected customers. Customers were asked to take the following actions: Customer Instructions: Please stop using and discard any of the Ammonia L3K reagent lots listed above in your inventory; Contact your distributor to discuss replacement product. Distributor Instructions: Please send the "IMPORTANT PRODUCT CORRECTION Customer Notification" provided to all customers that received Sekisui Diagnostics Ammonia LJK from the listed lot numbers; Complete, sign and return the attached CONFIRMATION OF NOTIFICATION form by FAX to the number provided. This will: Indicate receipt of this Field Correction, and confirmation of notification of customers that received impacted customers; Act as confirmation of destruction of affected product in inventory; Allow for issuance of replacement product. Customers with questions were instructed to contact Technical Services at 1-800-565-0265 or email [email protected].
Quantity in commerce: 774 Liters bulk and 565 kits
Distribution: Worldwide Distribution - US including DE, KS, FL, TX, CA, MI, TN, MA, ID, NJ, RI, IL and Internationally to Austria, Mexico, Canada, India, South Korea, China, Spain, South Korea, and Sri Lanka
Product codes and lots: Catalog Number: 293-80-91; Lot Numbers: 48737, 48962, 49087, 49220, 49258 and Catalog Numbers: 293-10; Lot Numbers: 48967, 49330, 49331, 49515

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1078-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1078-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-23

Product code JIF

K033921Class IAmmonia-L3k Assay, Catalogue Number 233-10Diagnostic Chemicals , Ltd. / cleared 2004-03-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)