Z-1500-2020Class II

Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use

Name: Z-1500-2020 Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use
Creator: The Binding Site Group, Ltd.
Published: 2019-11-06
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2019-11-06 / Terminated / root cause: manufacturing process

FDA source

The Binding Site Group, Ltd. began a recall of Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319 on 2019-11-06. FDA classified it as Class II and gives the reason as "It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to...". 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-1500-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-06
Posted: 2020-03-13
Terminated: 2022-09-08
Recalling firm: The Binding Site Group Ltd.
Product: Rheumatoid Factor (RF) Kit for use on SPAPLUS, for in-vitro diagnostic use, Product code: LK151.S.A. , UDI: 05051700018319
Product code: DHR System, Test, Rheumatoid Factor
Reason for recall: It has been identified that the rheumatoid factor (RF) calibrator values over recover in comparison to the reference material RF serum. This could result in reporting falsely abnormal results which may lead to unnecessary additional serological testing.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: It has been identified that the Rheumatoid Factor calibrator values, for LK151.S.A lot 428217, over recover in comparison to the reference material RF serum, NIBSC. To address this, the calibrator concentration values for the calibrators (SC151.A - E lot 448765) supplied in this kit have been adjusted to align more closely with the reference material. Due to the adjustment of the calibrator values, users may observe a decrease of approximately 21% in patient results in comparison to results obtained using previous calibrator values. In the absence of adopting these changes identified in the field safety notice, there is a risk, when using the affected kit, of reporting falsely abnormal results which may lead to unnecessary additional serological testing. The recalling firm issued a field safety notice along with an e-back form via email to the firm's US agent in CA on 11/6/2019. The US agent was instructed to send the field safety notice and e-back form to its customer via email. The field safety notice issued provides affected customers with reassigned calibrator values as well as a reassigned target and acceptance range for the quality controls provided with kit lot 428217 of LK151.S.A. The FSN instructs customers to input the adjusted values into the assay parameters on the SPAPLUS instrument instead of those supplied on the QC certificate.
Quantity in commerce: 30 kits
Distribution: Distributed in CA.
Product codes and lots: Lot 428217 (Expiry date: 30-APR-2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1500-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1500-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-25	2020-03-13

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)