LeadCare Plus-QC issues

Hello Patricia.  I had a call today with Katie Quatman and Andrea Fisher from Meridian/Magellan regarding the QC issues with the LeadCare II test kits.  The QC issues are failures on both level 1 and 2 and fail by resulting lower than the expected ranges.  The company is working to trace back the QC failure issue to the treatment reagent vials.  They have a new manufacturer making the plastic vials.  For LeadCare II users there are 5 kit lots that appear to be affected.  There will be a technical bulletin coming from the company this Friday regarding this and the FDA is aware and working with the company on this.  Meridian will replace the test kits  that have failed QC at no cost.  The technical bulletin coming out will give details on how to return affected kits for replacements.

Thank you so much for the timely information Karen! That is what is so great about this group!

Hi Karen,
When you get the bulletin, could you please send it to me?  Our main lab runs this instrument but there's a bunch of them in our primary care clinics. 
Thanks,
rmakiya@chw.org

Hello Patricia and Reine.  I am attaching the notice I received from Magellan. Affected kit lots are 2013M, 2014M, 2015M, 2016M and 2017M. 

In a nutshell, "At this time, Magellan is not aware of any complaints or reports from the field of false suppression involving patient blood samples tested with the impacted LeadCare lots; however, Magellan has conducted numerous studies and experiments to understand the root cause of this phenomenon and we currently believe that this issue has the potential to affect patient blood samples.  Because the impacted LeadCare lots could potentially underestimate blood lead levels when processing capillary blood samples, we recommend discontinuing the use of the impacted lots.  Laboratories should review results generated with the impacted lots.  Magellan is recommending retesting suspect results below 5 ug/dL."

"The current hypothesis for root cause is the occurrenc of an anomaly in the manufacture of a single lot of plastic caps and tubes by a new supplier...."


My plan is 1) have a report built in Epic that will pull any patients tested with these kit lot numbers to determine the scope of potentially affected patients.  2) prepare a technical bulletin with the recall information for my CLIA medical directors to review and approve of for distribution to the pediatricians.  3) Provide each pediatrician with a list of their affected patients 4) discuss with our Legal department and the medical directors if a waiver for the patients would be appropriate if they decline re-testing after reviewing the manufacturer recommendations for this recall.

Magellan-FEI 1218996_Direct Customer Notification-REMOVAL_COOR-L_FINAL-C1.pdf

Also, the LeadCare II instrument is a POC instrument - to clarify from the opening statement for this discussion.  It is classified as CLIA Waived for capillary blood testing for lead.

I missed this thread and the QC issues until yesterday when one of our sites said they had a recall notice.  There is also an expanded recall that includes 2101M, 2103M, 2105M, 2106M and 2107M.
I did call Telcor yesterday and they gave me a way to filter the results by kit number since we use MTE to enter the results.  That will atleast help gather the information to send to the doctors and sites.  We currently have 11 sites that use the instrument.