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 Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.

Recommended Action

Per FDA guidance

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 representative within 5 working days of receiving this notification. Transmission of this Important information: 3. This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. 4. Please transfer this notice to other organizations on which this action has an impact. 5. Please maintain awareness on this notice and resulting action for an appropriate period to ensure effectiveness of the corrective action.