FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas
Summary
The FDA issued a Class II for FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie by The Binding Site Group, Ltd.. Reason: The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values..
Details
Source
Device Recall
External ID
Z-2030-2021
Action Date
2021-07-14
Status
Terminated
Category
device
Product Description
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
Lot/Code Info: Lot Numbers: 487719/ Exp: 31-Jul-2022, 480133/ Exp: 30-Sep-2022, Lot 457890/ Exp: 30-Sep-2022
Reason for Recall
The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-20
Company
Birmingham
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 153 device recalls issued in the same week, part of 403 device-related FDA actions this month.
The Binding Site Group, Ltd. has 5 FDA actions in our database, including 3 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (The Binding Site Group, Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does The Binding Site Group, Ltd. have FDA actions?
The Binding Site Group, Ltd. has 5 FDA actions in our database, including 3 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2030-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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