OtherOWF
H. PYLORI STAT - PAK
Received Dec 7, 2004 · Event occurred Oct 13, 2004
Report 2431980-2004-00001 · MDR key 5101371
Device
Generic name
Ivd. Rapid Detection Of Ab To H. Pylori
Manufacturer
Chembio Diagnostic Systems, Inc.Catalog number
HP133
Lot number
HP111703/1
Product problems
- False Negative Result
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
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
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.
Remedial action
- Replace