Z-2030-2021Class II

FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for...

Name: Z-2030-2021 FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for...
Creator: The Binding Site Group, Ltd.
Published: 2021-05-20
License: https://open.fda.gov/license/

The Binding Site Group Ltd. / initiated 2021-05-20 / Terminated

FDA source

The Binding Site Group, Ltd. began a recall of 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... on 2021-05-20. FDA classified it as Class II and gives the reason as "The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2030-2021
Classification: Class II
Status: Terminated
Initiated: 2021-05-20
Posted: 2021-07-07
Terminated: 2025-02-04
Recalling firm: The Binding Site Group Ltd.
Product: 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
Product code: DFH Kappa, Antigen, Antiserum, Control
Reason for recall: The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.
FDA 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 [email protected] 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.
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, 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.
Product codes and lots: Lot Numbers: 487719/ Exp: 31-Jul-2022, 480133/ Exp: 30-Sep-2022, Lot 457890/ Exp: 30-Sep-2022

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2030-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2030-2021	Class II	Terminated	Voluntary: Firm initiated	2021-07-14	2021-07-07

Product code DFH

K070900Class IIFreelite Human Kappa and Lambda Free Diagnostic Test Kits for Use on the Roche Cobas Integra 400/400 Plus Analyzer KitThe Binding Site, Ltd. / cleared 2007-11-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)