Recall Z-2212-2017— Acumedia Manufacturers, Inc.
Class III · Terminated
Class III FDA medical device recall by Acumedia Manufacturers, Inc., initiated 2016-08-08, terminated 2017-06-02. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C..
- Recalling firm
- Acumedia Manufacturers, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2016-08-08
- Terminated
- 2017-06-02
- Firm location
- Lansing, MI, United States
Product description
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
Reason for recall
Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C.
Data sourced from openFDA. This site is unofficial and independent of the FDA.