FDA Adverse Event
Malfunction
Summary report: N
CLEARVIEW HCG DEV(URINE)20T
MDR report key: 22160666
·
Received June 6, 2025
Report
- Report Number
- 3005641941-2025-00001
- Event Type
- Malfunction
- Date Received
- June 6, 2025
- Date of Event
- May 8, 2025
- Report Date
- June 6, 2025
- Manufacturer
- ABON BIOPHARM (HANGZHOU) CO., LTD.
- Product Code
- JHI
- UDI-DI
- 06952999409538
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS MDR IS BEING FILED FOR THIS PRODUCT, FHC-102 ALERE HCG DEVICE (URINE) 20T, LOT 0000970784, AS THIS PRODUCT IS SAME/SIMILAR TO PRODUCT WHICH IS MARKETED IN THE US UNDER 510(K) K993317.
Description of Event or Problem · 0
ON THE (B)(6) 2025 ABBOTT WAS NOTIFIED BY CUSTOMER TO REPORT 2 POTENTIAL FALSE NEGATIVE ON CLEARVIEW HCG CASSETTE LOT NUMBER 0000970784. THE ALLEGED FALSE NEGATIVE OCCURRED ON FHC-102T PRODUC. CUSTOMER REPORTED 2 POTENTIAL FALSE NEGATIVE ON CLEARVIEW HCG CASSETTE LOT NUMBER 0000970784. 1 PATIENT IS INVOLVED, WITH A QUESTION OVER THE 2ND PATIENT. PATIENT WAS SENT TO EARLY PREGNACY UNIT AND HAD EARLY PREGANCY SCAN 24 HOURS LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1492638 | CLEARVIEW HCG DEV(URINE)20T | (HCG) PREGNANCY TEST DEVICE (URINE) | JHI | ABON BIOPHARM (HANGZHOU) CO., LTD. | CASSETTE | 0000970784 | 06952999409538 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |