IHEALTH
Report
- Report Number
- 3008573045-2024-00032
- Event Type
- Malfunction
- Date Received
- April 18, 2025
- Date of Event
- August 28, 2024
- Report Date
- October 31, 2024
- Manufacturer
- ANDON MEDICAL CO.,LTD
- Product Code
- QKP
- PMA / PMN Number
- EUA210470
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
1) CUSTOMER REPORTING FALSE NEGATIVE DUE TO NEGATIVE IHEALTH TESTS TAKEN ON (B)(6) 2024. COMPARISON WAS MADE TO ACCESSBIO ((B)(6) POSITIVE), GENABIO ((B)(6) POSITIVE), AND ACCESS BIO ((B)(6) POSITIVE). 2) THE IHEALTH TEST KIT IS AUTHENTIC AS IT WAS PURCHASED FROM AMAZON. 3) CUSTOMER NO FOLLOW UP PCR TEST. 4) THE MANUFACTURER RETESTED THE LOT (241CO20712) SAMPLES AT 2024-09-03, NO FALSE NEGATIVE WERE DETECTED. (NOTE: THERE IS A LOT NUMBER WRITING ERROR, THIS IS THE CORRECTED CONTENT, THE ORIGINAL DESCRIPTION. WAS "LOT (241CO20703)", THE LOT INFORMATION PROVIDED BY THE CUSTOMER AND THE LOT NUMBER OF SAMPLES TEST REPORT IS CORRECT).
1) CUSTOMER REPORTING FALSE NEGATIVE DUE TO NEGATIVE IHEALTH TESTS TAKEN ON (B)(6) 2024. COMPARISON WAS MADE TO ACCESSBIO ((B)(6) POSITIVE), GENABIO ((B)(6) POSITIVE), AND ACCESS BIO ((B)(6) POSITIVE). 2) THE IHEALTH TEST KIT IS AUTHENTIC AS IT WAS PURCHASED FROM AMAZON. 3) CUSTOMER NO FOLLOW UP PCR TEST. 4) THE MANUFACTURER RETESTED THE LOT (241CO20703) SAMPLES AT (B)(6) 2024, NO FALSE NEGATIVE WERE DETECTED.
EVENT DETAILS: I ORDERED A BOX OF TWO FOR SERIAL TESTING AFTER A KNOWN EXPOSURE AT HOME. THE CONTROL LINE DID NOT SHOW UP FOR 30 MIN SO I KNEW SOMETHING WAS WRONG WITH THE TEST. BOTH TESTS WERE NEGATIVE DESPITE TESTING POSITIVE WITH TWO OTHER TESTS/BRANDS, MY EXPOSURE AND SEVERE SYMPTOMS. I'VE NEVER TAKEN A COVID TEST THAT DID THIS BEFORE. IT'S RIDICULOUS THAT I HAVE TO EMAIL TO GET A REFUND WHEN IT WAS CLEARLY A FAULTY TEST. NOW, I HAVE TO SPEND ANOTHER ROUND FOR TESTS WHEN THE FIRST ONE SHOULD HAVE WORKED AND THEN USE THE SECOND OR OTHER TESTS WHEN I AM FEELING BETTER TO COME OUT OF ISOLATION. BUT NO, I HAD TO USE OTHER TESTS I HAD TO CONFIRM A POSITIVE TWO TIMES. I AM LUCKY I HAD THE OTHER BRANDS. I THINK YOU ARE IN THE BUSINESS OF SELLING FAULTY TESTS SO PEOPLE THINK THEY ARE NEGATIVE AND MUST BUY MORE TO MAKE SURE. I WON'T FALL FOR THAT GIMMICK. AT THIS POINT I WANT A REFUND NOW, BUT I'LL JUST LET YOU KNOW THAT NO MATTER WHEN YOU DO, I WILL NEVER BUY THIS BRAND AGAIN. UNRELIABLE. I HAVE PICTURES OF THE OTHER TESTS SHOWING POSITIVE. TWO SEPARATE DAYS. AND NOW YOUR WEBSITE SAYS IT WILL TAKE A LONG TIME. WHAT A POOR EXCUSE. IF YOU CAN'T MAKE RELIABLE TESTS OR PROVIDE PRODUCT SUPPORT IN A TIMELY MANNER, IT'S BEST YOU CHANGE TO A BUSINESS YOU CAN DO INSTEAD OF RIPPING SICK PEOPLE OFF.
EVENT DETAILS: I ORDERED A BOX OF TWO FOR SERIAL TESTING AFTER A KNOWN EXPOSURE AT HOME. THE CONTROL LINE DID NOT SHOW UP FOR 30 MIN SO I KNEW SOMETHING WAS WRONG WITH THE TEST. BOTH TESTS WERE NEGATIVE DESPITE TESTING POSITIVE WITH TWO OTHER TESTS/BRANDS, MY EXPOSURE AND SEVERE SYMPTOMS. I'VE NEVER TAKEN A COVID TEST THAT DID THIS BEFORE. IT'S RIDICULOUS THAT I HAVE TO EMAIL TO GET A REFUND WHEN IT WAS CLEARLY A FAULTY TEST. NOW, I HAVE TO SPEND ANOTHER ROUND FOR TESTS WHEN THE FIRST ONE SHOULD HAVE WORKED AND THEN USE THE SECOND OR OTHER TESTS WHEN I AM FEELING BETTER TO COME OUT OF ISOLATION. BUT NO, I HAD TO USE OTHER TESTS I HAD TO CONFIRM A POSITIVE TWO TIMES. I AM LUCKY I HAD THE OTHER BRANDS. I THINK YOU ARE IN THE BUSINESS OF SELLING FAULTY TESTS SO PEOPLE THINK THEY ARE NEGATIVE AND MUST BUY MORE TO MAKE SURE. I WON'T FALL FOR THAT GIMMICK. AT THIS POINT I WANT A REFUND NOW, BUT I'LL JUST LET YOU KNOW THAT NO MATTER WHEN YOU DO, I WILL NEVER BUY THIS BRAND AGAIN. UNRELIABLE. I HAVE PICTURES OF THE OTHER TESTS SHOWING POSITIVE. TWO SEPARATE DAYS. AND NOW YOUR WEBSITE SAYS IT WILL TAKE A LONG TIME. WHAT A POOR EXCUSE. IF YOU CAN'T MAKE RELIABLE TESTS OR PROVIDE PRODUCT SUPPORT IN A TIMELY MANNER, IT'S BEST YOU CHANGE TO A BUSINESS YOU CAN DO INSTEAD OF RIPPING SICK PEOPLE OFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 18312 | IHEALTH | CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | QKP | ANDON MEDICAL CO.,LTD | ICO-3000 | 241CO20712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |