Optilite Freelite Mx Kappa Free Kit LK016.M.OPT.ARecalls & reported problems
The Binding Site Group Limited · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Nov 18, 2020Class IITerminated
Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values.
Z-0943-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Kappa, Antigen, Antiserum, Control devices
- Optilite Freelite Kappa Kit LK016.OPT.AThe Binding Site Group Limited · Kappa, Antigen, Antiserum, Control4 reports
- Freelite® Human Kappa Free Kit for use on the Roche cobas® systems LK016.CBThe Binding Site Group Limited · Kappa, Antigen, Antiserum, Control2 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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