PAKAUTO
Received Oct 24, 2018 · Event occurred Oct 2, 2018
Report 2183608-2018-00031 · MDR key 8002478
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
(B)(6) 2018. THE CUSTOMER RETURNED KIT FROM LOT 3006837 (PA) WAS TESTED IN PARALLEL WITH AN IMMUCOR-WKS RETENTION KIT FROM LOT 3006837 (PA) ON (B)(6) 2018. THE CUSTOMER RETURNED KIT AND THE RETENTION KIT FROM LOT 3006837 (PA) GAVE NEGATIVE CONTROL OD AVERAGE VALUES IN THE IIB/IIIA ROWS THAT DID NOT MEET IFU VALIDITY CRITERIA. THE NEGATIVE SERUM CONTROL IS RUN IN DUPLICATE WITH EACH TEST RUN. THE NEGATIVE SERUM CONTROL SHOULD GIVE AN AVERAGE OD VALUE OF < OR EQUAL TO 0.160 OD IN THE IIB/IIIA ROWS. THE CUSTOMER COMPLAINT ((B)(4)) WAS REPRODUCED. THE CUSTOMER WAS PERFORMING VALIDATION AND STUDY TESTING USING THE KIT. CORRECTIVE ACTION IS BEING TAKEN THROUGH FA-WKS-18-008, TO NOTIFY CUSTOMERS OF THE AFFECTED PAKAUTO LOT.
Remedial action
- Recall