MalfunctionJIP
OCCULT BLOOD TEST KIT
Received Dec 28, 1995
Report MW4000984 · MDR key 29088
Device
Product problems
- Product Quality Problem
- Incorrect Or Inadequate Test Results
Patient
*
- Unknown (for use when the patient's condition is not known)
Narrative
Description of Event or Problem
AFTER TESTING, IT WAS FOUND THAT THE EXPECTED RESULTS COULD NOT BE SUCCESSFULLY REPRODUCED. THE POSITIVE AND NEGATIVE CONTROLS WERE CHECKED FOR THE APPROPRIATE COLOR REACTION AND THE MFR'S SPECIFIED COLOR CHANGE WAS NOT ACHIEVED. IT IS IMPOSSIBLE TO CONFIRM THE PT RESULTS IF THE CONTROLS CAN NOT BE VERIFIED. THIS PRODUCT DOES NOT MEET THE REQUIREMENTS OF THE AGENCY THAT THIS FACILITY MUST ABIDE BY.