Z-0274-2022Class II

Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use...

Name: Z-0274-2022 Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use...
Creator: The Binding Site Group, Ltd.
Published: 2021-10-15
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2021-10-15 / Terminated / root cause: manufacturing process

FDA source

The Binding Site Group, Ltd. began a recall of Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S on 2021-10-15. FDA classified it as Class II and gives the reason as "Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6...". 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-0274-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-15
Posted: 2021-11-19
Terminated: 2025-02-04
Recalling firm: The Binding Site Group Ltd.
Product: Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S
Product code: DEH Lambda, Antigen, Antiserum, Control
Reason for recall: Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 10/15/2021 (revised letter 10/25/2021), the firm sent an "Urgent Medical Device Correction" Notification to customers via email to inform them that it has identified an imprecision at top of calibration curve, where the calibration curves produced using specific lots have a higher activity than routinely expected and that there may be a decrease separation between calibrator point 5 and 6 which can be exacerbated when calibrator 6 activity reaches the optical ceiling of the analyzer and may result in an inaccurate value being reported. Customers are instructed to: Adapt the calibration curve to run as a 5-point curve with immediate effect as below 1. Stop using the 6-point calibration curve for the affected kit lots. 2. Run a 5-point calibration curve by entering values for Calibrator 1 to Calibrator 5 only as found on the Quality Control Certificate provided within the kit in ascending order on Page 1 of the Item parameters. Leave Standard 6 blank. Ensure the Auto Fill button is pressed after entering the value for Calibrator 5 on page 1. The analyser will automatically calculate and enter the revised measuring ranges on Item pages 3 and 4. 3. View Item parameter pages 3 and 4 to ensure correct value entry. 4. Before requesting calibration, view the CALIB screen and delete any existing rack position and OD information shown for STD-6 of the corresponding assay. 5. Calibration curves must only be accepted if Absorbance values increase with increasing concentration as stated in Section D.2.2 of the SPAPLUS Reference Guide (FIN012). -The expiry of the above kit lots has been reduced from 31/OCT/2022 to 30/APR/2022. Update records accordingly as the affected kit lots must not be used beyond this point. 6. Fill out and return the TSWS18 E-Back form to [email protected] or to your local The Binding Site Representative within two weeks of receiving this notification. For question/further information, contact Local Binding Site Representative or Techn
Quantity in commerce: 2,254 kits
Distribution: U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada
Product codes and lots: Model Number: LK018.S UDI Code: 05051700006477 Lot Number: 472776 Model Number:LK018.10S UDI Code: 05051700012201 Lot Number: 472664

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0274-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0274-2022	Class II	Terminated	Voluntary: Firm initiated	2021-12-01	2021-11-19

Product code DEH

K140396Class IIFreelite Human Lambda Free KitThe Binding Site Group , Ltd. / cleared 2014-04-16

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)