Z-1267-2014Class II

AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative...

Name: Z-1267-2014 AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative...
Creator: AMS Diagnostics, LLC
Published: 2014-02-11
License: https://open.fda.gov/license/

Ams Diagnostics / initiated 2014-02-11 / Terminated

FDA source

AMS Diagnostics, LLC began a recall of AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum on 2014-02-11. FDA classified it as Class II and gives the reason as "Marketing the devices outside 510(k) requirements". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1267-2014
Classification: Class II
Status: Terminated
Initiated: 2014-02-11
Posted: 2014-03-21
Terminated: 2016-09-29
Recalling firm: Ams Diagnostics
Product: AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: Marketing the devices outside 510(k) requirements
FDA root cause: No Marketing Application
Action: AMS Diagnostics sent a Recall Notification letter dated February 11, 2014 to all affected customers. The letter instructed the customers to: 1) Review their inventory for the lots listed and if they currently have them, to discard and notify the firm for a replacement. 2) If they don't have the lots listed, please check the box, sign, date and return the letter via fax at (954) 217-0046 or email to [email protected]. Customers with questions were instructed to call 954-217-0040 ext. 302. For questions regarding this recall call 954-217-0040.
Quantity in commerce: 167 kits
Distribution: Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.
Product codes and lots: Model Numbers: 40072, 40146, 81046. Lot codes: 131083, 131084, 131085, 131086, 131087, 131088, 131089, 1310810, 1310811, 1310812, 1310813, 1310814, 1310815, 141081.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1267-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1267-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-21
Z-1268-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-21
Z-1269-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-21

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)