Z-1089-2017Class III

Optilite IgG4 Kit

Name: Z-1089-2017 Optilite IgG4 Kit
Creator: The Binding Site Group, Ltd.
Published: 2016-12-23
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2016-12-23 / Terminated

FDA source

The Binding Site Group, Ltd. began a recall of Optilite IgG4 Kit Product Code: LK009.OPT.A on 2016-12-23. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1089-2017
Classification: Class III
Status: Terminated
Initiated: 2016-12-23
Posted: 2017-07-27
Terminated: 2017-05-03
Recalling firm: The Binding Site Group Ltd.
Product: Optilite IgG4 Kit Product Code: LK009.OPT.A
Product code: CFN Method, Nephelometric, Immunoglobulins (G, A, M)
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
FDA root cause: Under Investigation by firm
Action: Customer notification letters were sent on 12/23/16. The Binding Site recommends to continue testing on the kit as normal and refer to the measuring ranges and limit of quantification stated in the notice and as indicated in the amended insert (INS009.OPT.A, Version: 21st December 2016) provided with this notification. The notice needs to be passed on to all those who need to be aware within the organization or to any Organization where the potentially affected devices have been transferred. Return the completed E-Back Form to your local Binding Site Representative for records and note that The Binding Site intends to report this correction to the FDA recall coordinator. If you have any questions contact Technical Services.
Quantity in commerce: 9 users
Distribution: U.S. distribution to the following; FL, TX, PA, CA, MA, WA, MI, CT. No foreign distribution.
Product codes and lots: Lot #401413

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1089-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1089-2017	Class III	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-24

Product code CFN

K150526Class IIOptilite IgG4 KitThe Binding Site Group , Ltd. / cleared 2015-05-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)