CLASS II Device recall · Reported 1 Dec 2021 · FDA Enforcement Report
Freelite Human Lambda Free Kit (for use on the Spaplus) recalled
The Binding Site Group is recalling Freelite Human Lambda Free Kit (for use on the Spaplus), distributed in 13 states. The recall was initiated on 15 Oct 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0274-2022
- FDA event ID
- 88921
- Recalling firm
- The Binding Site Group, Birmingham
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Oct 2021
- FDA classified
- 19 Nov 2021
- Reported
- 1 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 15 Oct 2021 | Recall initiated by company | |
| 19 Nov 2021 | Classified by FDA | +35 days |
| 1 Dec 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada
CaliforniaColoradoFloridaIllinoisIndianaKentuckyLouisianaMichiganNew YorkOklahomaSouth DakotaTexasVirginia
Questions about this recall
Why was it 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.
Which lots are affected?
Model Number: LK018.S UDI Code: 05051700006477 Lot Number: 472776 Model Number:LK018.10S UDI Code: 05051700012201 Lot Number: 472664
Where was it sold?
U.S.: CA, CO, FL, IL, IN, KY, LA, MI, NY, OK, SD, TX and VA. O.U.S.: Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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