CLASS II Device recall · Reported 1 Feb 2017 · FDA Enforcement Report

Tryptic Soy Agar, Acumedia PN 7100, and sizes recalled

Acumedia Manufacturers is recalling Tryptic Soy Agar, Acumedia PN 7100, and sizes, distributed in 21 states. The recall was initiated on 22 Apr 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes7100A Lot 108166C 7100B, Lot 108166B 7100C, Lot 108166A 7100D, Lot 108166A 7100CAR, lot 108166B 108-1, Lot 108166B

Quantity recalled482

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1093-2017
FDA event ID: 76053
Recalling firm: Acumedia Manufacturers, Lansing, MI
Classification: Class II
Status: Terminated
Recall initiated: 22 Apr 2016
FDA classified: 25 Jan 2017
Reported: 1 Feb 2017
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

22 Apr 2016	Recall initiated by company
25 Jan 2017	Classified by FDA	+278 days
1 Feb 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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.

Arkansas California Connecticut Florida Georgia Idaho Illinois Indiana Maryland Maine Michigan North Carolina North Dakota New York Ohio Oregon Tennessee Texas Utah Virginia

Questions about this recall

Is Tryptic Soy Agar, Acumedia PN 7100, and sizes recalled?

Yes. Acumedia Manufacturers recalled Tryptic Soy Agar, Acumedia PN 7100, and sizes on 22 Apr 2016. The recall is Class II and its status is Terminated. Recall number Z-1093-2017.

Why was it recalled?

Which lots are affected?

7100A Lot 108166C 7100B, Lot 108166B 7100C, Lot 108166A 7100D, Lot 108166A 7100CAR, lot 108166B 108-1, Lot 108166B

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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