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Optilite IgG4 Kit Product Code: LK009.OPT.A

FDA Recall #Z-1089-2017 — Class III — December 23, 2016

Recall #Z-1089-2017 Date: December 23, 2016 Classification: Class III Status: Terminated

Product Description

Optilite IgG4 Kit Product Code: LK009.OPT.A

Reason for Recall

A change to the lower end of the measuring range and product insert did not reflect the change.The measuring range provided in instrument parameters is correct but contradicts the information provided in the product insert

Recalling Firm

The Binding Site Group, Ltd. — Birmingham, N/A

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Devices

Product Quantity

9 users

Distribution

U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution.

Code Information

Lot #401413

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

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