FDA Medical Device Recalls (openFDA)
Acumedia Manufacturers, Inc.: Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds
- Recall number
- Z-2212-2017
- Recalling firm
- Acumedia Manufacturers, Inc.
- Product
- Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds
- Status
- Terminated
- Initiated
- 2016-08-08
- Posted
- 2017-06-01
- 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
- On 8/8/2016 and 10/6/2016, notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, and information for the correction to product.
- Quantity
- 10 units
- Distribution
- US in the state of IL
- Lot, serial or model codes
- PN 91081C, Lot 108367A PN 91081C, Lot 107632A
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSG
- 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