Z-0553-2018Class II

Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro...

Name: Z-0553-2018 Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro...
Creator: The Binding Site Group, Ltd.
Published: 2018-01-04
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2018-01-04 / Terminated

FDA source

The Binding Site Group, Ltd. began a recall of Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the... on 2018-01-04. FDA classified it as Class II and gives the reason as "The low and high controls for the product are returning results above the assigned values". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0553-2018
Classification: Class II
Status: Terminated
Initiated: 2018-01-04
Posted: 2018-02-08
Terminated: 2020-06-09
Recalling firm: The Binding Site Group Ltd.
Product: Rheumatoid Factor (RF) Kit for use on SPAPLUS, Product #LK151.S.A Intended for the quantitative in-vitro measurement of rheumatoid factor in serum using the Binding Site SPAPLUS analyser. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis. This test should be used in conjunction with other laboratory and clinical findings
Product code: DHR System, Test, Rheumatoid Factor
Reason for recall: The low and high controls for the product are returning results above the assigned values.
FDA root cause: Under Investigation by firm
Action: Binding Site sent an Urgent Field Safety Notice dated December 22, 2017. Advise on action to be taken by the User: " The new QC values detailed below should be used for the remainder of the shelf life of this Rheumatoid Factor Kit for use on SPAPLUS. "Input the revised QC values into your SPAPLUS instrument "Sign and return the TSWS18 E-Back Form accompanying this notification within 5 business days "Refer to Section 9 of the Product Insert SIN282(.A) if QCs are out of range following reassignment. For further questions, please call (858) 453-9177.
Quantity in commerce: 49 kits to the U.S. office (32 kits further distributed)
Distribution: US Distribution was made to CA. There was no foreign/military/government distribution.
Product codes and lots: Lot #416595, Exp. 31/03/2018; UDI #05051700018319

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0553-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0553-2018	Class II	Terminated	Voluntary: Firm initiated	2018-02-14	2018-02-08

Product code DHR

K160070Class IIRheumatoid Factor (RF) Kit for use on SPAPLUSThe Binding Site Group , Ltd. / cleared 2016-12-07

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)