BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. KIT GRP A STREP 30 TEST VERITOR; ANTIGENS, ALL GROUPS, STREPTOCOCCUS SPP.
|
Back to Search Results |
|
Catalog Number 256040 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/19/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
|
|
Event Description
|
Report 2 of 5.It was reported when using the kit grp a strep 30 test veritor the user visually read the test cartridge and perceived the result as positive, while the test cartridge reader gave a negative result for a patient sample.No health impact or consequence reported.
|
|
Search Alerts/Recalls
|
|
|