FDA Adverse Event
Other
Summary report: N
H. PYLORI STAT - PAK
MDR report key: 5101371
·
Received December 7, 2004
Report
- Report Number
- 2431980-2004-00001
- Event Type
- Other
- Date Received
- December 7, 2004
- Date of Event
- October 13, 2004
- Report Date
- December 6, 2004
- Manufacturer
- CHEMBIO DIAGNOSTIC SYSTEMS, INC.
- Product Code
- OWF
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT LOT IN QUESTION WAS BULK MATERIAL FOR FURTHER PACKAGING BY (B)(4). EVAL OF DEVICE SHOWED THAT IT MET RELEASE CRITERIA.
Description of Event or Problem · 1
ON (B)(6) 2004, A DISTRIBUTOR/REPACKAGER. (B)(4), EMAILED SAYING THAT HP111703/1 OF H. PYLORI STAT- PAK HAS GIVEN 18 NEGATIVES IN A SUSPECT POPULATION. THREE OF THESE WERE CONFIRMED POSITIVE BY ELISA. THERE WAS NO INVOLVEMENT IN ANY DEATH OR SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | H. PYLORI STAT - PAK | IVD. RAPID DETECTION OF AB TO H. PYLORI | OWF | CHEMBIO DIAGNOSTIC SYSTEMS, INC. | HP111703/1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |