Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049

FDA Recall #Z-0769-2021 — Class II — December 10, 2020

Recall #Z-0769-2021 Date: December 10, 2020 Classification: Class II Status: Terminated

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.

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