Z-1070-2017Class II

Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera...

Name: Z-1070-2017 Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera...
Creator: The Binding Site Group, Ltd.
Published: 2014-09-11
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2014-09-11 / Terminated / root cause: manufacturing process

FDA source

The Binding Site Group, Ltd. began a recall of Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917 and Hitachi Modular P... on 2014-09-11. FDA classified it as Class II and gives the reason as "Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1070-2017
Classification: Class II
Status: Terminated
Initiated: 2014-09-11
Posted: 2017-01-23
Terminated: 2017-05-03
Recalling firm: The Binding Site Group Ltd.
Product: Human lgG4 Subclass Liquid Reagent Kits Human lgG1& lgG2 Antisera, lgG3 & 4 Latex reagent and lgG Antisera for use on Hitachi 911/912/917 and Hitachi Modular P Product Code LK009.H/LK001.H This kit is intended for qualifying human IgG subclasses 1,2,3 and 4 immunoglobulins in serum on the Beckman Coulter AU series. Meaurement of these immunoglobulins ais in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents
Product code: CFN Method, Nephelometric, Immunoglobulins (G, A, M)
Reason for recall: Customer complaints identified that samples containing extremely high IgG4 levels exhibit antigen excess and will yield spuriously low IgG4 results.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Binding Site sent an Important Information letter dated September 30, 2014, Customers were instructed to retain the notification for records and additional instructions with the firm stating they were updating the instructions for use. Customers with questions were advised to contact their Binding Site representative or [email protected].
Distribution: Worldwide Distribution - US including n FL, OH, TN, MN, NW, MI, CA. and Internationally to Canada, France, UK, Spain, Germany, Czech Republic, Belgium, Italy, Australia, Brazil, Chile, China, Costa Rica, Kuwait, New Zealand, Oman, Pakistan, Portugal, Sweded, Taiwan, and Turkey.
Product codes and lots: All lots.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1070-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1067-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-23
Z-1068-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-23
Z-1069-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-23
Z-1070-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-23
Z-1071-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-23
Z-1072-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-23
Z-1073-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-23

Product code CFN

K090920Class IIHuman Igg Subclass Liquid Reagent Kits (for Use on Hitachi 911/ 912/ 917 and Modular P)The Binding Site, Ltd. / cleared 2009-12-30

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)