Recall Z-0283-2019— Acumedia Manufacturers, Inc.
Class III · Terminated
Class III FDA medical device recall by Acumedia Manufacturers, Inc., initiated 2018-08-02, terminated 2020-12-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection and isolation of Listeria monocytogenes from foods and environmental samples in a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.. Reason: Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on distributed product listed the expiration date as November 30, 2021..
- Recalling firm
- Acumedia Manufacturers, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2018-08-02
- Terminated
- 2020-12-18
- Firm location
- Lansing, MI, United States
Product description
Palcam Agar Base, Acumedia, PN 7669, Product Usage - Dehydrated culture media used with supplements as a selective and differential medium for the detection and isolation of Listeria monocytogenes from foods and environmental samples in a laboratory setting. Not intended for use in the diagnosis of disease or other conditions in humans.
Reason for recall
Expiration date on the label is incorrect. Correct expiration date was November 30, 2020 and label on distributed product listed the expiration date as November 30, 2021.
Data sourced from openFDA. This site is unofficial and independent of the FDA.