Recall Z-2030-2021 ยท DFH Kappa, Antigen, Antiserum, Control
The Binding Site Group, Ltd.
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
| Date | May 20, 2021 |
| Status | Terminated |
| Reason | The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values. |
| Root cause | Under Investigation by firm |
| Action | Between the dates of 5/20-21/2021, The Binding Site (TBS) issued a "Urgent Medical device Correction" via email to affected consignees. In addition to informing consignees about the recall, the firm ask consignees to take the following actions: 1, TBS have completed reassignment of the controls; updated target values and assigned acceptance ranges are provided in Table 2. Users may continue to use remaining kits with the following revised assigned control values. 2. Please return you completed TSWS18 E-Back Form (attached) to technical.support@bindingsite.com or to your local Binding Site |
| Distribution | 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, Luxembour |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070900 | FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT The Binding Site, Ltd., Nov 30, 2007 |