Recall Z-2221-2017— Acumedia Manufacturers, Inc.
Class III · Terminated
Class III FDA medical device recall by Acumedia Manufacturers, Inc., initiated 2016-09-25, terminated 2017-06-02. FDA's recall record names no specific 510(k) clearance for this event. 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. 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
- 2016-09-25
- Terminated
- 2017-06-02
- Firm location
- Lansing, MI, United States
Product description
Urea Base Agar, Acumedia PN 7226 Urea Agar Base is used with agar for the differentiation of microorganisms on the basis of urease production
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.