Catalog Number 07P51-20 |
Device Problem
High Test Results (2457)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 01/16/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
There was no further patient information provided by the customer.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 7p51-20 that has a similar product distributed in the us, list number 7p51-21.
|
|
Event Description
|
The customer reported false positive alinity i b-hcg results on one patient.The results provided were: on (b)(6) 2020 sid(b)(6) = 38.99iu/l (>/=25.00iu/l = positive) / retest on same tube = <2.30iu/l x2 (<5.00iu/l = negative) / new sample same patient = negative.There was no reported impact to patient management.
|
|
Manufacturer Narrative
|
The ticket search determined normal complaint activity for lot 06112ui00, and no trends were identified for the product.Return testing was not completed as returns were not available.Accuracy testing was performed with a retained kit of lot 06112ui00 and all validity and acceptance criteria were met, demonstrating that this lot is performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the customer's observation.A review of the product labeling concluded that the issue is sufficiently addressed.Based on the investigation no product deficiency was identified for the alinity i total b-hcg reagent, lot 06112ui00.
|
|
Search Alerts/Recalls
|