FDA Adverse Event
Summary report: N
CMV LGG TEST KIT
MDR report key: 29531
·
Received December 14, 1995
Report
- Report Number
- MW4001027
- Date Received
- December 14, 1995
- Report Date
- November 29, 1995
- Manufacturer
- CLARK LABORATORIES, INC.
- Product Code
- LFZ
- Report Source
- Voluntary report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
RPTR CALLED TO REPORT PROBLEMS WITH FALSE NEGATIVE TEST RESULTS. THE FIRM WAS DOING SIDE BY SIDE VALIDATION OF THE CMV LGG TEST KITS USING TWO LOT NUMBERS WITH THE FIRST LOT OUT OF 40 SAMPLES, THERE WERE 16 NEGATIVE RESULTS. 8 OF 16 WERE DETERMINED TO BE FALSE NEGATIVES. WITH THE SECOND LOT OUT OF 12 SAMPLES, THERE WERE 6 NEGATIVE RESULTS. 4 OF 6 WERE FALSE NEGATIVES. RPTR DID NOT REPORT THE RESULTS OF MFR. THE FIELD OFFICER INDICATED IT WAS IMPORTANT TO DO SO BECAUSE THE FIRM NEEDED TO CONDUCT AN INVESTIGATION INTO THE MATTER AND POSSIBLY INITIATE A RECALL. TESTING WAS DONE IN 8/95, WAS TOLD IT COULD BE DEVASTATING FOR ORGAN RECIPIENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CMV LGG TEST KIT | CMV LGG TEST KIT | LFZ | CLARK LABORATORIES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |