Magellan Lead Care recall

No luck. I'm still waiting for replacement kits from the first recall. I faxed in my replacement form to them on 6/25/2021. I still haven't heard anything, so I called today. Their lines are all backed up and you are unable to leave a voicemail since it is full. I tried calling customer support, but they told me that isn't their department and that I have to call tech support. I said I couldn't reach tech support and all they said was that I can email them at LeadCareSupport@magellandx.com.

I suggest reaching out to your sales rep and asking for reimbursement for all test kits that you used that were affected.  We had used 3 boxes of affected lot numbers so we asked to be reimbursed for those boxes and they agreed.  We now have 4 more boxes used up that were affected with the additional recall and we will be asking for additional reimbursement.   I am also concerned about even starting up testing again as I do not want to get caught with additional lots being added again.  We had 3 of 5 lot numbers the first time around and all 3 boxes we used after were affected by the additional lot numbers added.  I have asked for an update from my sales rep and if he sends one I will share it. 

Did you get the letter from them? If not I can send you a copy. There is a form to complete to get replacements for kits that are recalled, but I suspect they will be very slow to send replacement kits just due to the volume of responses they are getting. I was told that I could order new kits in the meanwhile that will, of course, be lots not effected by the recall. 

Lisa,

Do you have the letter for the second recall? I got the first letter, but not the second one for the second round of recalls.

If anyone could send any forms they have gotten, that would be great. I believe our clinics have the form for reimbursement of kits but Risk wants to talk to someone directly about the entire situation. Sounds like that won't be easy. 

You can get the letter from Magellan at https://www.magellandx.com/recall-contact-expanded/

20210706_CDC-HAN-00445_Recall_of_Lea.pdf

Mai - 
I got through and spoke with Pria.  Very helpful.  Was able to fill out form and submit per site that had the recalled Lot # 's.
They are replacing on a first come , first serve basis.  There is back order on current stock and they are replacing as quickly has they can.  We have not received our replacement kits yet.  I spoke with Magellan just before the 4th of July holiday.  They are swamped!!! and overwhelmed! and if you are in POC you know what I'm talking about.  We have enough stock to hold us for a few weeks. We have plan B ready to go.  

Nope, I have emailed and tried calling for a month. Voicemail is full. I have submitted my forms. Now I am just waiting. Currently having to send out the lead testing since we have no stock of unaffected lot numbers! 

Has anyone had issues with QC coming in on other lot numbers that weren't in the recall?  I had a site call me this morning that had issues with lot numbers 2109 and 2111.  I did have them call tech support to trouble shoot but very leery with them now.

One of my clinics had an issue with 20109M. I had called tech support to see if it was a lot that Magellan was having an issue with and it just wasn't officially on the recall list yet. Tech support said it wasn't. Tech Support reiterated that if the clinic had QC issues, they should have called in to Tech Support for trouble shooting.

Our organization has decided to cease lead testing on the Leadcare II until we have received official word from Meridian that the issue has been identified and fixed.  Luckily we only have one analzyer at this time, but are looking to expand this testing once they have fixed the problem.   We cannot afford to continue testing and be told again that additional lots are now affected.

Can anyone share how they are dealing with this recall?  Are you calling all patients in for repeat testing?  Are you re-testing with the LeadCare, or sending to a reference lab?  Have you seen any discrepancies?
My institution has 6 sites using the LeadCare II.  We do not have a Magellan representative.  Each site purchases reagents through a distributor, so the POCT Lab has no control over lot numbers.  We are at the mercy of the testing personnel to keep records of lot numbers and patients tested.  Obtaining this information has not been easy. 
I need to report to our event response team tomorrow, so any information you can share ASAP would be appreciated:)