ClearanceBrief
Recall Z-2584-2017 ยท JSI Culture Media, Selective And Differential

Acumedia Manufacturers, Inc.

Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential enrichment of Listeria spp. From foods, dairy and environmental samples.

DateNov 30, 2015
StatusTerminated
ReasonContamination of product with possible Bacillus spp
Root causeProcess design
ActionOn 11/30/2015 and 1/21/2016, 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 offers replacement product.
Quantity28 units
DistributionWorldwide Distribution - US Nationwide in the states of WI, NJ, NY and countries of BRAZIL, ECUADOR, SINGAPORE, CANADA,
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.