Z-1093-2017Class II

Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes

Name: Z-1093-2017 Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes
Creator: Acumedia Manufacturers, Inc.
Published: 2016-04-22
License: https://open.fda.gov/license/

Neogen Culture Media / initiated 2016-04-22 / Terminated / root cause: design

FDA source

Acumedia Manufacturers, Inc. began a recall of Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes on 2016-04-22. FDA classified it as Class II and gives the reason as "light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. While there is no change in growth performance of this medium, the formation of particulate matter may be misinterpreted as...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1093-2017
Classification: Class II
Status: Terminated
Initiated: 2016-04-22
Posted: 2017-01-25
Terminated: 2018-09-19
Recalling firm: Neogen Culture Media
Product: Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes
Product code: JSG Culture Media, Non-Selective And Non-Differential
Reason for recall: light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. While there is no change in growth performance of this medium, the formation of particulate matter may be misinterpreted as growth in poured plates thereby leading to inaccurate counts.
Root cause tag: design
FDA root cause: Component design/selection
Action: Neogen sent a Recall Notification dated March 8, 2016, to all affected customers on April 22, 2016. via e-mail. The recall notification included a description of the reason for the recall, affected product, and offer for replacement. If any Tryptic Soy Agar from this lot remains in your inventory, and you would like to replace this lot, please contact the customer service team at Neogen Corporation by email at [email protected] or by telephone at (800)-234-5333. We would like to assure you that we are committed to providing products that meet our strict quality standards for your testing needs. Neogen will investigate this isolated incident to determine the root cause and implement measures to ensure that this issue does not happen in the future.
Quantity in commerce: 482
Distribution: Worldwide Distribution - US Distribution to the states of : AR, CA, CT, FL, GA, ID, IL, IN, MD, ME, MI, NC, ND, NY, OH, OR, TX, TN, UT, VA, WI. and to the countries of : CANADA, UK, ISRAEL, MEXICO, AUSTRALIA, COLOMBIA, TAIWAN, BRAZIL, CHILE and INDONESIA.
Product codes and lots: 7100A Lot 108166C 7100B, Lot 108166B 7100C, Lot 108166A 7100D, Lot 108166A 7100CAR, lot 108166B 108-1, Lot 108166B

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1093-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1093-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-25

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)