Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
FDA Recall #Z-0769-2021 — Class II — December 10, 2020
Product Description
Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
Reason for Recall
The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.
Recalling Firm
Remel Inc — Lenexa, KS
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
637 units
Distribution
Distribution in United States - AL, FL, GA, LA MS, NC, SC, TN
Code Information
Lot 150237
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.