Recall Z-1093-2017— Acumedia Manufacturers, Inc.
Class II · Terminated
Class II FDA medical device recall by Acumedia Manufacturers, Inc., initiated 2016-04-22, terminated 2018-09-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes. Reason: light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. While there is no change in growth performance of this medium, the formation of particulate matter may be misinterpreted as growth in poured plates thereby leading to inaccurate counts..
- Recalling firm
- Acumedia Manufacturers, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-04-22
- Terminated
- 2018-09-19
- Firm location
- Lansing, MI, United States
Product description
Tryptic Soy Agar, Acumedia PN 7100 500g, 2Kg, 10Kg, and 50Kg sizes
Reason for recall
light precipitate may form in prepared plates of Acumedia Tryptic Soy Agar (7100) Lot# 108166. While there is no change in growth performance of this medium, the formation of particulate matter may be misinterpreted as growth in poured plates thereby leading to inaccurate counts.
Data sourced from openFDA. This site is unofficial and independent of the FDA.