Z-2110-2020Class II

Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea...

Name: Z-2110-2020 Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea...
Creator: The Binding Site Group, Ltd.
Published: 2019-10-07
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2019-10-07 / Terminated / root cause: manufacturing process

FDA source

The Binding Site Group, Ltd. began a recall of Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components) on 2019-10-07. FDA classified it as Class II and gives the reason as "Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the reference material RF serum. This...". 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-2110-2020
Classification: Class II
Status: Terminated
Initiated: 2019-10-07
Posted: 2020-05-22
Terminated: 2022-01-11
Recalling firm: The Binding Site Group Ltd.
Product: Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)
Product code: DHR System, Test, Rheumatoid Factor
Reason for recall: Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the reference material RF serum. This could result in reporting abnormal (false positive) results, which may lead to unnecessary additional serological testing and a delay in treatment.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The field safety notice was issued from the firm's UK office to their US office. The US office notified affected end users in the US via Field Safety Notice, dated 09 October 2019 that was sent via email on 9 Oct 2019. The FSN stated the following: 1) That it has been identified that the assigned Rheumatoid Factor (RF) calibrator value, for LK151.0PT.A lot 428224, over recovers by 7% in comparison to the reference material RF serum, NIBSC. Ref 64/002 (WHO Standard 64/2). 2) The firm has assessed risk of this over recovery and determined that there is no clinical risk, and that the kit can continue to be used providing the control results are within their specified acceptance ranges. There is however, a risk of reporting abnormal results which may lead to unnecessary additional serological testing. 3) Although the affected kit, lot 428224, may continue to be used, The Binding Site has calculated an adjustment factor of 0.93 that may be applied to sample results in order to align results to the reference material. They advise that to apply the adjustment factor, the final result for the sample should be multiplied by 0.93. Calibrator and control values for future lots of LK151.0PT.A, will be aligned with the reference material. 4) An e-back form (TSWS18) was provided to affected customers along with the FSN. The FSN requests the customer to complete, sign and return the e-back form to [email protected] or to their local Binding Site representative within one week of receiving the notification to confirm that they have received and understood the FSN. 5) If further information is required, contact local Binding Site Representative or Technical Support Group, UK: +44(0) 1214569696, [email protected]
Quantity in commerce: 478 kits
Distribution: US: AL, AR, AZ, FL, GA, KY, MA, MD, MI, MN, MS, NC, NE, NY, OR, PA, TX, VT, WA, WI OUS: None
Product codes and lots: Kit Lot Number: 428224

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2110-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2110-2020	Class II	Terminated	Voluntary: Firm initiated	2020-06-03	2020-05-22

Product code DHR

K162263Class IIOptilite Rheumatoid Factor KitThe Binding Site Group , Ltd. / cleared 2017-05-03

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)