CLASS II Device recall · Reported 14 Jul 2021 · FDA Enforcement Report
Freelite Human Kappa Free Kit recalled by The Binding Site Group
The Binding Site Group is recalling Freelite Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie, distributed nationwide in the US. The recall was initiated on 20 May 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-2030-2021
- FDA event ID
- 88064
- Recalling firm
- The Binding Site Group, Birmingham
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 May 2021
- FDA classified
- 7 Jul 2021
- Reported
- 14 Jul 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 20 May 2021 | Recall initiated by company | |
| 7 Jul 2021 | Classified by FDA | +48 days |
| 14 Jul 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.
Product as listed by the FDA
FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of CA, GA, FL, MA, MO, MI, WA, NY, PA, MN, AL, MD, OK, NE, IN, ID, OH, TX, HI, DC and the countries of Canada, Australia, Austria, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Switzerland, United Kingdom, Argentina, Egypt, GUADELOUPE, HONG KONG, India, Iran, Israel, Korea, Lebanon, Malaysia, Morocco, Oman, Singapore, Taiwan, Tunisia, Vietnam.
Nationwide AlabamaCaliforniaDistrict of ColumbiaFloridaGeorgiaHawaiiIdahoIndianaMassachusettsMarylandMichiganMinnesotaMissouriNebraskaNew YorkOhioOklahomaPennsylvaniaTexasWashington
Questions about this recall
Why was it recalled?
The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.
Which lots are affected?
Lot Numbers: 487719/ Exp: 31-Jul-2022, 480133/ Exp: 30-Sep-2022, Lot 457890/ Exp: 30-Sep-2022
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of CA, GA, FL, MA, MO, MI, WA, NY, PA, MN, AL, MD, OK, NE, IN, ID, OH, TX, HI, DC and the countries of Canada, Australia, Austria, Belgium, Bulgaria, Canada, Cyprus, Czech Republic, Denmark, Estonia, France, Germany, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Romania, Slovenia, Spain, Switzerland, United Kingdom, Argentina, Egypt, GUADELOUPE, HONG KONG, India, Iran, Israel, Korea, Lebanon, Malaysia, Morocco, Oman, Singapore, Taiwan, Tunisia, Vietnam.
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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