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NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the selecti...

FDA Recall #Z-1313-2016 — Class II — December 21, 2015

Recall #Z-1313-2016 Date: December 21, 2015 Classification: Class II Status: Terminated

Product Description

NEL GBS Medium 20 ml in 100x15mm plate (Standard Petri Dish) Catalog No.: P8000; For the selective enrichment and screening of Beta-Hemolytic Streptococcus agalactiae (Group B Strep).

Reason for Recall

Product marketed without a 510 (k)

Recalling Firm

Northeast Laboratory Services, Inc. — Winslow, ME

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

9300

Distribution

Nationwide Distribution.

Code Information

Al lot codes

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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