Z-2212-2017Class III

Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081

Name: Z-2212-2017 Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081
Creator: Acumedia Manufacturers, Inc.
Published: 2016-08-08
License: https://open.fda.gov/license/

Neogen Culture Media / initiated 2016-08-08 / Terminated / root cause: labeling and UDI

FDA source

Acumedia Manufacturers, Inc. began a recall of Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary... on 2016-08-08. 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-2212-2017
Classification: Class III
Status: Terminated
Initiated: 2016-08-08
Posted: 2017-06-01
Terminated: 2017-06-02
Recalling firm: Neogen Culture Media
Product: Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds
Product code: JSG Culture Media, Non-Selective And Non-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: On 8/8/2016 and 10/6/2016, notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, and information for the correction to product.
Quantity in commerce: 10 units
Distribution: US in the state of IL
Product codes and lots: PN 91081C, Lot 108367A PN 91081C, Lot 107632A

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2212-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2212-2017	Class III	Terminated	Voluntary: Firm initiated	2017-06-07	2017-06-01

Product code JSG

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)