FLOWFLEX PLUS RSV + FLU A/B + COVID HOME TEST

Additional Manufacturer Narrative

CASE OUTCOME: REFER TO CPUS260137 FORM B INVESTIGATION REPORT (PREVIOUS INVESTIGATION FOR THE SAME ISSUE). RETENTION SAMPLES FROM LOT RFC5118004 WERE TESTED AND MET THE QC CRITERIA. THE ISSUE WAS NOT FOUND IN THE RETAINED CASSETTES. THE COMPLAINT IS NOT CONFIRMED.

Description of Event or Problem

INVALID RESULT(S). WE GOT A CALL FROM A CUSTOMER THAT IS HAVING AN ISSUE WITH THE FLOWFLEX PLUS 4 N1 COVID 19, FLU A/B, RSV ANTIGEN TEST KIT. THE CUSTOMER RECENTLY PURCHASED THE KIT, SO THIS IS AN OUT OF BOX ISSUE. WHEN THE CUSTOMER PERFORMED THE TEST CORRECTLY WITH 4 DROPS IN THE S-WELL, THE TEST RESULT CAME BACK INVALID. THE TEST CASSETTE ONLY HAS 1 CONTROL LINE VISIBLE. THE CUSTOMER WAS ABLE TO PROVIDE A PICTURE OF THE TEST CASSETTE. WE ADVISED THE CUSTOMER THIS INFORMATION TO THE APPROPRIATE DEPARTMENT FOR REVIEW. THE CUSTOMER WILL WAIT FOR AN EMAIL RESPONSE FROM ACON LABS REGARDING THIS MATTER.

Additional Manufacturer Narrative

THE CURRENT COMPLAINT IS PENDING INVESTIGATION FROM ACON'S CONTRACT MANUFACTURER. ACON WILL SUBMIT A FOLLOW-UP MDR UPON INVESTIGATION COMPLETION. ANY ADDITIONAL INFORMATION RECEIVED BY ACON MAY BE INCLUDED WITH A FOLLOW-UP MDR.

Description of Event or Problem

INVALID RESULT(S). WE GOT A CALL FROM A CUSTOMER THAT IS HAVING AN ISSUE WITH THE FLOWFLEX PLUS 4 N1 COVID 19, FLU A/B, RSV ANTIGEN TEST KIT. THE CUSTOMER RECENTLY PURCHASED THE KIT, SO THIS IS AN OUT OF BOX ISSUE. WHEN THE CUSTOMER PERFORMED THE TEST CORRECTLY WITH 4 DROPS IN THE S-WELL, THE TEST RESULT CAME BACK INVALID. THE TEST CASSETTE ONLY HAS 1 CONTROL LINE VISIBLE. THE CUSTOMER WAS ABLE TO PROVIDE A PICTURE OF THE TEST CASSETTE. WE ADVISED THE CUSTOMER THIS INFORMATION TO THE APPROPRIATE DEPARTMENT FOR REVIEW. THE CUSTOMER WILL WAIT FOR AN EMAIL RESPONSE FROM ACON LABS REGARDING THIS MATTER.