Catalog Number 251184 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 01/07/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
|
|
Event Description
|
It was reported while using plate thayer-martin selective agar there was a failure to inhibit proteus.
|
|
Manufacturer Narrative
|
After further evaluation of the complaint, it has been determined that the previously submitted mfr report# was sent in error.This material # is an luo (laboratory use only) and does not meet the criteria of a medical device as stated in 21 cfr 803.Therefore, this complaint is not mdr reportable.
|
|
Event Description
|
It was reported while using plate thayer-martin selective agar there was a failure to inhibit proteus.
|
|
Search Alerts/Recalls
|