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Device recall: Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis

FDA enforcement event 77276 · Class III · initiated 25 Sep 2016 · status Terminated · terminated 2 Jun 2017

DeviceVoluntary: Firm initiated1 product recordLansing, MI

Acumedia Manufacturers, Inc. (Lansing, MI) initiated this device recall on 25 Sep 2016; FDA lists 1 product record under event 77276, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 5% of the 1,232 device enforcement events initiated in 2016 carry the same class.

Status: Terminated, terminated 2 Jun 2017. Initiation: voluntary: firm initiated. Acumedia Manufacturers, Inc. has 8 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Acumedia Manufacturers, Inc., Lansing, MI.

Reason for recall

"Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C."

Distribution

"Worldwide Distribution - US to AZ; Internationally to ECUADOR; CANADA; UK; BRAZIL"

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-2221-2017	Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production	28 units	Class III	Terminated	14 Jun 2017

Context

5%of 2016 device events are Class III1,232 events that year

1product record in this eventfirm median: 1

8events on this register for the firm

Other enforcement events for Acumedia Manufacturers, Inc.

Initiated	Product (first record)	Type	Class	Records
2 Aug 2018	Campylobacter Blood Free Selective Medium, PN 7527A Used with cefoperazone for the selective isolation of Campylobacter	Device	Class III	1
2 Aug 2018	Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and d	Device	Class III	1
8 Aug 2016	Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from s	Device	Class III	1
22 Apr 2016	Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes	Device	Class II	1
23 Mar 2016	Nutrient Gelatin, Acumedia Part Number 7471 A Product Usage: Nutrient Gelatin is used for the differentiation of microor	Device	Class III	1
30 Nov 2015	Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supple	Device	Class II	1
11 Sep 2015	Beef Extract Powder, Acumedia PN 7228 Product Usage: Beef Extract Powder is prepared and standardized for use in microbi	Device	Class III	1

All 8 events for Acumedia Manufacturers, Inc.

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Worldwide Distribution - US to AZ; Internationally to ECUADOR; CANADA; UK; BRAZIL"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 2 Jun 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.