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Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF… recallZ-0274-2022 · The Binding Site Group, Ltd. · initiated Oct 15, 2021

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from The Binding Site Group, Ltd. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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

Recall details

Recall number
Z-0274-2022
Status
Terminated
Initiated by the company
Oct 15, 2021
Recalling firm
The Binding Site Group, Ltd.
Quantity
2,254 kits
Product code
DEH
FDA submissions
K140396
Distribution
U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada

Product description

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

Code information (models, lots, serial numbers)

Model Number: LK018.S UDI Code: 05051700006477 Lot Number: 472776 Model Number:LK018.10S UDI Code: 05051700012201 Lot Number: 472664

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

Sources and updates

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