Z-2221-2017Class III

Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms...

Name: Z-2221-2017 Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms...
Creator: Acumedia Manufacturers, Inc.
Published: 2016-09-25
License: https://open.fda.gov/license/

Neogen Culture Media / initiated 2016-09-25 / Terminated / root cause: labeling and UDI

FDA source

Acumedia Manufacturers, Inc. began a recall of Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production on 2016-09-25. FDA classified it as Class III and gives the reason as "Storage temperature listed on the label was incorrect. Label stated 2-30C. Actual storage temperature is 2-8C". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2221-2017
Classification: Class III
Status: Terminated
Initiated: 2016-09-25
Posted: 2017-06-02
Terminated: 2017-06-02
Recalling firm: Neogen Culture Media
Product: Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
Product code: JSI Culture Media, Selective And Differential
Reason for recall: Storage temperature listed on the label was incorrect. Label stated 2-30C. Actual storage temperature is 2-8C.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Neogen Corporation sent a Product Notification dated September 25, 2016, to all affected consignees via email. The recall notification included a description of the reason for the recall, affected product, and information for the correction to product. Consignees were informed that an internal corrective action has been initiated and actions have been taken and implemented to prevent this situation from occurring again. The label has been corrected and existing inventory has been relabeled. For questions regarding this recall call 800-234-5333, ext 2362.
Quantity in commerce: 28 units
Distribution: Worldwide Distribution - US to AZ; Internationally to ECUADOR; CANADA; UK; BRAZIL
Product codes and lots: PN 7226A, Lot 108812A PN 7226B, Lot 108812A PN 7226A, Lot 107 699C

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2221-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2221-2017	Class III	Terminated	Voluntary: Firm initiated	2017-06-14	2017-06-02

Product code JSI

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)