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Microplate, truncated V-bottomed lots included in the above listed products Product Number: ...

FDA Recall #Z-0690-2013 — Class II — November 26, 2012

Recall #Z-0690-2013 Date: November 26, 2012 Classification: Class II Status: Terminated

Product Description

Microplate, truncated V-bottomed lots included in the above listed products Product Number: 1380 5465. DBS Microplate is a general purpose 96 well microplate used in the preparation and examination of specimens from the human body.

Reason for Recall

Truncated V-Bottomed Microplate Wells used in assays contain defective wells.

Recalling Firm

Perkinelmer — Waltham, MA

Classification

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

Product Type

Devices

Product Quantity

N/A

Distribution

Nationwide Distribution.

Code Information

Lot Numbers: 616792 , 617141 , 617980 , 618319, 618664, 618831, 619175

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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