CLASS III Device recall · Reported 1 Feb 2017 · FDA Enforcement Report

Optilite IgG4 Kit Product recalled by The Binding Site Group

The Binding Site Group is recalling Optilite IgG4 Kit, distributed in 8 states. The recall was initiated on 23 Dec 2016 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #401413

Quantity recalled9 users

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1089-2017
FDA event ID: 76131
Recalling firm: The Binding Site Group, Birmingham, N/A
Classification: Class III
Status: Terminated
Recall initiated: 23 Dec 2016
FDA classified: 24 Jan 2017
Reported: 1 Feb 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

23 Dec 2016	Recall initiated by company
24 Jan 2017	Classified by FDA	+32 days
1 Feb 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

Optilite IgG4 Kit Product Code: LK009.OPT.A

Where it was distributed

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

California Connecticut Florida Massachusetts Michigan Pennsylvania Texas Washington

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot #401413

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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