The Recall Desk
LowFDA (Devices)·Z-2221-2017·Announced 2017-06-14

Acumedia Urea Base Agar Recalled for Incorrect Storage Labeling

Acumedia is recalling Urea Base Agar because the label listed an incorrect storage temperature range.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a minor labeling error regarding storage temperature.

Plain-English summary

Acumedia Manufacturers, Inc. is recalling Urea Base Agar, Acumedia PN 7226. The product is used with agar for the differentiation of microorganisms on the basis of urease production.

The recall was initiated because the storage temperature listed on the label was incorrect. The label stated a range of 2-30°C, but the actual required storage temperature is 2-8°C.

The affected units include 28 units distributed worldwide to the US (Arizona), Ecuador, Canada, the UK, and Brazil. Specific lot numbers involved are PN 7226A Lot 108812A, PN 7226B Lot 108812A, and PN 7226A Lot 107 699C. Users should verify their product labels and contact the manufacturer for instructions.

The recalled product

Product
Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
Affected units
28

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

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

Distribution

Distributed in 1 state: