CLASS III Device recall · Reported 14 Jun 2017 · FDA Enforcement Report

Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used recalled

Acumedia Manufacturers is recalling Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation, distributed nationwide in the US. The recall was initiated on 25 Sep 2016 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesPN 7226A, Lot 108812A PN 7226B, Lot 108812A PN 7226A, Lot 107 699C

Quantity recalled28 units

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-2221-2017
FDA event ID: 77276
Recalling firm: Acumedia Manufacturers, Lansing, MI
Classification: Class III
Status: Terminated
Recall initiated: 25 Sep 2016
FDA classified: 2 Jun 2017
Reported: 14 Jun 2017
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Temperature Abuse
Device type: Other Medical Devices

Timeline

25 Sep 2016	Recall initiated by company
2 Jun 2017	Classified by FDA	+250 days
14 Jun 2017	Published in enforcement report	+12 days

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

Reason for recall

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

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production

Where it was distributed

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

Nationwide Arizona

Questions about this recall

Is Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation recalled?

Yes. Acumedia Manufacturers recalled Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation on 25 Sep 2016. The recall is Class III and its status is Terminated. Recall number Z-2221-2017.

Why was it recalled?

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

Which lots are affected?

PN 7226A, Lot 108812A PN 7226B, Lot 108812A PN 7226A, Lot 107 699C

Where was it sold?

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

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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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