MalfunctionJRI
CHIRON DIAGNOSTICS EXPRESS REACTION CUVETTES
Received Feb 1, 1997 · Event occurred Jan 10, 1997
Report 1519113-1997-00001 · MDR key 66930
Device
Generic name
Express Model 550/560 Reaction Cuvettes
Manufacturer
Chiron Diagnostics Corp.Model number
NACatalog number
751060
Lot number
1363 & 1369
Patient
NA
Narrative
Description of Event or Problem
A HOLE IN THE BOTTOM OF THE REACTION CUVETTES ALLOWED THE REAGENT/PT SAMPLE TO LEAK OUT OF THE BOTTOM OF THE CUVETTE, CAUSING NEGATIVE RESULTS. THE LAB DID NOT REPORT OUT ANY PT RESULTS. LAB PERSONNEL CALLED CO FIELD SERVICE PERSONNEL TO INVESTIGATE. THERE WAS NO SERIOUS INJURY OR DEATH.
Remedial action
- Recall