Z-1921-2016Class II

Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection...

Name: Z-1921-2016 Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection...
Creator: Remel Inc
Published: 2016-03-24
License: https://open.fda.gov/license/

Remel Inc / initiated 2016-03-24 / Terminated

FDA source

Remel Inc began a recall of Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in... on 2016-03-24. FDA classified it as Class II and gives the reason as "Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1921-2016
Classification: Class II
Status: Terminated
Initiated: 2016-03-24
Posted: 2016-06-07
Terminated: 2017-02-13
Recalling firm: Remel Inc
Product: Oxoid Nitrocefin (+ Reconstitution Fluid Batch) REF: SR0112C, Oxoid Ltd. For the rapid chromogenic detection of beta-lactamase activity in bacterial cells. in vitro diagnostic
Product code: JTT Susceptibility Test Powders, Antimicrobial
Reason for recall: Individual bottles of product may produce weak beta-lactamase reactions. Use may result in delayed or false negative reporting.
FDA root cause: Under Investigation by firm
Action: Customers were notified by letter beginning on March 24, 2016.
Quantity in commerce: 2 units were imported and distributed domestically
Distribution: US distribution in MO.
Product codes and lots: Lot 1717357 Exp: 31Aug2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1921-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1921-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-07

Product code JTT

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)