ClearanceBrief
Recall Z-1748-2015 ยท JSG Culture Media, Non-Selective And Non-Differential

Remel Inc

Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per case (100 plates). Blood agar is a solid medium recommended for use in qualitative procedures for the cultivation of a wide variety of microorganisms and visualization of hemolytic reactions.

DateJun 10, 2015 (initiated May 4, 2015)
StatusTerminated
ReasonProduct may be contaminated with Listeria monocytogenes.
Root causeMaterial/Component Contamination
ActionThe recalling firm sent the recall notification letter (dated May 1, 2015) to all customers on 5/4/2015 via standard mail.
Quantity845/10/10-plate pack cases
DistributionNationwide Distribution.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.