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Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and moni...

FDA Recall #Z-1050-2017 — Class II — November 28, 2012

Recall #Z-1050-2017 Date: November 28, 2012 Classification: Class II Status: Terminated

Product Description

Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.

Reason for Recall

Calibration curve activity has increased over time in the kit lots listed.

Recalling Firm

The Binding Site Group, Ltd. — Birmingham

Classification

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

Product Type

Devices

Product Quantity

1,002

Distribution

U.S. distribution to the following; CA, TX, HI, GA, PA, UT, NY, OK, ID, MA, AZ. Foreign distribution to the following; Australia, Bulgaria, Denmark, Hong Kong, Ireland, Israel, Japan, New Zealand, Taiwan, Belgium, France, Italy, Spain.

Code Information

Lot #323278, 327963

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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