Catalog Number 08D06-39 |
Device Problem
Low Test Results (2458)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 08d06-39 that has a similar product distributed in the us, list number 08d06-41.There is no additional patient information provided due to privacy issues.
|
|
Event Description
|
The customer reported (b)(6) architect syphilis results on one patient.The results provided were: initial = (b)(6) / (b)(6).The customer retested the sample = (b)(6) /(b)(6).There was no reported impact to patient management.
|
|
Manufacturer Narrative
|
A review of tickets determined that there is a slightly elevated complaint activity for lot 91382li00, but no trends were identified.Sensitivity testing was performed with a retained kit of lot 91382li00 and replicates of a sensitivity panel.Results of this setup did not implicate that the performance of the used lots is negatively impacted.No false non-reactive results were obtained.Return testing was not completed as returns were not available.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of labeling concluded that the issue is adequately addressed.Based on the investigation no product deficiency was identified for architect syphilis tp, lot 91382li00.
|
|
Search Alerts/Recalls
|