FDA Medical Device Recalls (openFDA)
Acumedia Manufacturers, Inc.: Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
- Recall number
- Z-2221-2017
- Recalling firm
- Acumedia Manufacturers, Inc.
- 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
- Status
- Terminated
- Initiated
- 2016-09-25
- Posted
- not on file
- Terminated
- 2017-06-02
- Reason
- Storage temperature listed on the label was incorrect. Label stated 2-30C. Actual storage temperature is 2-8C.
- Root cause
- Error in labeling
- Action
- Neogen Corporation sent a Product Notification dated September 25, 2016, to all affected consignees via email. The recall notification included a description of the reason for the recall, affected product, and information for the correction to product. Consignees were informed that an internal corrective action has been initiated and actions have been taken and implemented to prevent this situation from occurring again. The label has been corrected and existing inventory has been relabeled. For questions regarding this recall call 800-234-5333, ext 2362.
- Quantity
- 28 units
- Distribution
- Worldwide Distribution - US to AZ; Internationally to ECUADOR; CANADA; UK; BRAZIL
- Lot, serial or model codes
- PN 7226A, Lot 108812A PN 7226B, Lot 108812A PN 7226A, Lot 107 699C
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSI
- Firm FEI
- 1120041
- Firm city
- Lansing
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28