API® NH ZYM B X2

Additional Manufacturer Narrative

DEVICE NOT RETURNED TO MANUFACTURER.

Description of Event or Problem

A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT (B)(6) AND NEISSERIA MENINGITIDIS IN ASSOCIATION WITH THE API® 2 ZYM B X2 REAGENT WHEN USED WITH THE API® NH TEST STRIP. THE ZYM B REAGENT TURNED A DARK ORANGE COLOR BEFORE THEIR STATED EXPIRY DATE. TESTS PERFORMED WITH THE REAGENT OBTAINED A MISIDENTIFICATION OF THE TESTED ORGANISM. THE CUSTOMER STATED THAT SINCE THESE ISOLATES ARE ROUTINELY IDENTIFIED BY TWO METHODS IN THEIR LABORATORY, NO INCORRECT RESULTS WERE REPORTED TO THE PHYSICIAN; PATIENT TREATMENT WAS NOT AFFECTED. BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

Additional Manufacturer Narrative

A CUSTOMER IN THE (B)(6) CONTACTED BIOMÉRIEUX TO REPORT MISIDENTIFICATION OF NEISSERIA GONORRHOEAE AND NEISSERIA MENINGITIDIS IN ASSOCIATION WITH THE API® 2 ZYM B X2 REAGENT WHEN USED WITH THE API® NH TEST STRIP. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED. THE CUSTOMER NOTED ZYM B VIALS BATCH N° 100451550 (EXP. 17 JAN 2016) AND BATCH N° 1004339020 WERE DEEP ORANGE COLOR. THE CUSTOMER ALSO OBSERVED API® NH KIT BATCH N°1004676470 EXP. 17 JAN 2017 INCLUDED A ZYM B VIAL BATCH N°1004658750, ALSO DEEP ORANGE COLOR. ALL OF THOSE VIALS WERE INTACT, UNDAMAGED AT RECEPTION AND STORED CORRECTLY AT 2-8°C. THE CUSTOMER OBTAINED (USING THE ZYM B VIAL BATCH N° 1004515550 OF THE KIT REF. 70493 BATCH 1004558330 EXP. 15 DEC 2016) A MISIDENTIFICATION BETWEEN N. GONORRHEAE AND N. MENINGITIDIS. THE TEST WAS PERFORMED WITH AN API® NH STRIP BATCH N° 1004676470 (KIT) EXP. 17 JAN 2017. THE CUSTOMER DIDN'T PERFORM THE QUALITY CONTROL TEST. THE VIAL WAS PART OF ZYM B BATCHES WITH THE PREVIOUS FORMULATION. THE STRAINS WERE IDENTIFIED BY TWO (2) METHODS AT THE LABORATORY : NO FALSE RESULT WAS GIVEN. CONCERNING THE ZYM B VIAL BATCH N° 1004339020, IT EXPIRED ON 06 SEP 2016. IT WAS IN THE API® LISTERIA KIT REF. 10300 BATCH N° 1004418250 EXP. 06 SEP 2016. INVESTIGATION : CHECK OF KIT BATCH N°1004558330 REF. 70493: - PRESENCE OF THE FLYER IN THE KIT. - ZYM B VIAL: DEEP ORANGE/RED COLOR. CHECK OF THE FLYER BATCH N° 1004676470 API NH REF. 10400: - NO FLYER IN THE KIT (WHICH IS NORMAL). - ZYM B VIAL: YELLOW COLOR. CONCLUSION OF THE INVESTIGATION : THE ZYM B VIAL OF THE CUSTOMER BATCH N° 1004339020 IS EXPIRED, SO NO POSSIBILITY TO VERIFY THE ZYM B VIALS ASPECT. HOWEVER, ANOTHER BATCH OF THE SAME WAS CHECKED AND THAT VIAL SHOWED A DEEP-ORANGE/RED COLOR, PHENOMENON FOUND BY THE CUSTOMER. FOR THE REFERENCE 70493, A FLYER IS INTRODUCED IN EACH KIT IN ORDER TO INFORM THE CUSTOMER ON THE POTENTIAL DEEP-ORANGE/RED COLOR OF ZYM B VIALS. THAT FLYER MENTIONS: "IN ORDER TO EXCLUDE ANY DEFECTIVE REAGENTS, IT IS MANDATORY TO PERFORM THE QUALITY CONTROL RECOMMENDED IN THE SECTION "READING AND INTERPRETATION" OR "USE OF REAGENTS" OF THE ASSOCIATED STRIP PACKAGE INSERT, EACH DAY OF USE AND UNTIL THE AMPULE'S EXPIRATION DATE IS REACHED". INDEED, THE GENERAL REAGENTS PACKAGE INSERT INDICATES: "CHECK THE APPEARANCE OF THE REAGENT BEFORE TRANSFERRING IT INTO THE DROPPER BOTTLE. AFTER TRANSFERRING THE CONTENT OF THE AMPULE INTO THE DROPPER BOTTLE, WRAP THE BOTTLE IN THE ALUMINUM FOIL. SHADES OF COLOR MAY BECOME DROPPER OVER TIME". LIKEWISE, THE API® NH STRIPS REF.10400 MENTIONS : "BEFORE USE, CHECK THAT THE PACKAGING AND COMPONENTS ARE INTACT. THE ZYM B AND JAMES REAGENTS ARE VERY SENSITIVE TO LIGHT : CHECK THE APPEARANCE OF THE REAGENTS BEFORE TRANSFERRING THEM INTO THE DROPPER BOTTLES. EXPOSURE TO LABORATORY LIGHTING FOR A SHORT PERIOD OF TIME (APPROX.1 HOUR) WILL DAMAGE THE REAGENT". CONCERNING THE API® NH KIT BATCH N° 1004676470 INCLUDING THE ZYM B VIAL BATCH N° 1004586570, THE REAGENT ASPECT CONFORMS (YELLOW COLOR).