Description of Event or Problem · 0
I PURCHASED 10 CUE COVID -19 TEST KITS ((B)(6)) AND A CUE TEST READING UNIT ((B)(6)) IN (B)(6) 2023. I USED 3 OF THOSE TEST KITS, AND ALL RESULTS WERE NEGATIVE (PERHAPS FALSE NEGATIVES, BASED ON THE INFORMATION I READ AT THE FDA WEBSITE TODAY). I TRIED TO USE ANOTHER TEST KIT LAST WEEK, BUT THE CUE APP ON MY IPAD REFUSED TO PROCEED WITHOUT SCANNING A BAR CODE THAT WAS SUPPOSED TO HAVE BEEN INCLUDED IN THE BOX OF KITS I HAD BOUGHT. THERE WAS NO "REGISTRATION CARD" IN THAT BOX. I TRIED TO GET HELP, OR ANY EXPLANATION FROM CUE: THE WEBSITE DOES NOT HAVE ANY ACCESS TO HELP, AND DOES NOT MENTION THE FDA WARNING AT ALL. I SENT 2 EMAILS TO [email protected] OVER THE PAST WEEK, WITH NO RESPONSE AT ALL. I DIALED THE PHONE NUMBER THAT I FOUND ON THE BOX OF KITS; THE FIRST ANSWERING MESSAGE ADMITTED THAT CUE OWNS THE NUMBER; THE SECOND MESSAGE STATED THAT THE NUMBER WAS "TEMPORARILY" NOT IN SERVICE. I TRIED TO USE THE CHAT FUNCTION I FOUND IN A GOOGLE-SEARCH-SUPPLIED SITE (HELP.CUEHEALTH.COM), BUT COULD NOT GET ANY HUMAN OR USEFUL BOT RESPONSE: THE BOT JUST TOOK YET ANOTHER MESSAGE, AND PROMISED SOMEONE WOULD EVENTUALLY SEND ME AN EMAIL. AND NOW, I SEE THAT THE FDA HAS PUBLISHED A WARNING (WITHOUT PUBLICIZING IT ADEQUATELY) THAT THE QUALITY OF ALL 10 OF THE TESTS I PURCHASED, 3 OF WHICH I USED TO OBTAIN NEGATIVE RESULTS, IS DANGEROUSLY COMPROMISED. THE FDA RECOMMENDS THAT I DISCARD ALL REMAINING TESTS. WHY DIDN'T THE FDA ORDER CUE TO: (1) RECALL ALL UNUSED TESTS, (2) STOP SELLING THE BAD TESTS IMMEDIATELY, (3) OFFER FULL REFUNDS FOR THE DEFECTIVE TESTS? CUE DEMANDS THAT USERS OF CUE TESTS USE THE CUE APP (WHICH DEMANDS EXTENSIVE USER INFORMATION), SO CUE OBVIOUSLY COULD SEND RECALL NOTICES TO EVERY SINGLE USER OF THEIR DEFECTIVE TESTS. THE LACK OF FDA COMMUNICATIONS WITH USERS, AND THE LACK OF ENFORCEMENT PENALTIES AGAINST CUE, UNDERMINES A LOT OF THE CONFIDENCE I EVER HAD IN THE FDA (WHICH, AFTER ALL THE SCANDALS OVER THE YEARS, SUCH AS OTHER UNPUBLICIZED AND/OR RIDICULOUSLY OVER-DELAYED RECALLS, IS NOT MUCH). IF THE FDA HAD FOUND CUE'S PROBLEMS, AND ORDERED CUE TO DEAL APPROPRIATELY WITH THOSE PROBLEMS, MUCH EARLIER, I WOULD NOT HAVE SPENT (B)(6) ON DANGEROUSLY DEFECTIVE FDA-APPROVED TESTS. ARE YOU INVESTIGATING THE CONTINUED EFFICACY OF ANY OTHER TESTS? I USED (B)(6) UNTIL THEY WENT OUT OF BUSINESS; DID THEY TOO CHANGE THEIR FORMULATIONS WITHOUT TELLING YOU? IS THAT WHY THEY EVENTUALLY WENT OUT OF BUSINESS? OR, DID THEY FALSIFY THE TEST DATA ON WHICH FDA RELIES IN ISSUING EMERGENCY USE LICENSES? IT REALLY IS TIME FOR THE FDA TO MOVE INTO THE SAME TECHNICALLY ADVANCED ERA AS THE MANUFACTURERS AND PRODUCERS THEY ARE SUPPOSED TO REGULATE. THERE ARE NO RESULTS, BECAUSE THE FDA ALLOWED CUE TO SELL EXPENSIVE, DEFECTIVE TEST KITS TO USERS WHO STILL REMAIN UNINFORMED ABOUT THE PROBLEMS BY EITHER THE FDA OR CUE. REF REPORT: MW5156291.