Z-1301-2018Class II

Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is...

Name: Z-1301-2018 Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is...
Creator: The Binding Site Group, Ltd.
Published: 2018-03-09
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2018-03-09 / Terminated / root cause: labeling and UDI

FDA source

The Binding Site Group, Ltd. began a recall of Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The... on 2018-03-09. FDA classified it as Class II and gives the reason as "The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1301-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-09
Posted: 2018-04-03
Terminated: 2020-06-22
Recalling firm: The Binding Site Group Ltd.
Product: Binding Site Optilite Beta-2-Microglobulin Urine Kit, Ref LK043.L.OPT.A, IVD. The firm name on the label is The Binding Site Group Ltd., Birmingham, U.K. The Optilite Beta-2-Microglobulin (2M) Urine kit is intended for the quantitative in-vitro measurement of beta-2-microglobulin in urine using the Binding Site Optilite analyser to aid in the diagnosis of active rheumatoid arthritis and kidney disease. This test should be used in conjunction with other laboratory and clinical findings.
Product code: JZG System, Test, Beta-2-Microglobulin Immunological
Reason for recall: The product is not meeting the antigen excess protection claim of up to 760mg/L, as stated in the Instructions for Use.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The recalling firm notified their U.S. location by letter dated 3/6/2018 via email on 3/9/2018.
Quantity in commerce: 20 kits distributed to the U.S.
Distribution: US Distribution was made to CA. There was no foreign/military/government distribution.
Product codes and lots: Lot 407460, UDI 05051700017688

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1301-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1301-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-11	2018-04-03

Product code JZG

K122066Class IIHuman Beta-2 Microglobulin Urine Kit for Use on the SpaplusThe Binding Site Group , Ltd. / cleared 2012-08-30

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)