CAPI 3 IMMUNOTYPING

Description of Event or Problem

18 AUGUST 2021: THE CUSTOMER OBSERVED THAT ONE KIT OF THE CAPI 3 IMMUNOTYPING ANTISERA CARTRIDGE OUT OF THE 50 KITS RECEIVED, LOT 11021/01, PRESENTED WITH DISCORDANT RESULTS. VISUAL INSPECTION IDENTIFIED THAT TWO OF THE ANTISERA ANTI-IGA AND ANTI-IGM WERE REVERSED IN THE POSITIONS WITHIN THE SEALED CARTRIDGE. NO DISCREPANT PATIENT LABORATORY REPORTS WERE RELEASED. THERE WERE NO REPORTS OF IMPACT TO PATIENT MANAGEMENT.

Additional Manufacturer Narrative

19 AUGUST 2021: THE CUSTOMER CONTACTED SEBIA INC., (US SUBSIDIARY OF SEBIA), TECHNICAL SUPPORT TEAM IN REGARDS TO AN INVERSION OF TWO ANTISERA IN A SINGLE CAPI 3 IMMUNOTYPING CARTRIDGE. NO PATIENT RESULTS WERE IMPACTED. ALL OTHER PRODUCTS RECEIVED BY THE CUSTOMER WERE IN COMPLIANCE. SEBIA INC.,(US IMPORTER) INSPECTED ALL CAPI 3 IMMUNOTYPING STOCK AND ALL PRODUCTS WERE COMPLAINT. PRODUCT ALERT LETTERS WERE SENT TO ALL CUSTOMERS GLOBALLY THAT RECEIVED CAPI 3 IMMUNOTYPING KITS OF LOT 11021/01. THE LETTER INSTRUCTED CUSTOMERS TO VISUALLY INSPECT KITS, REVIEW QUALITY CONTROL IF PRODUCT WAS PLACED INTO USE FOR CONFORMANCE. A TOTAL OF (B)(4) KITS WERE SHIPPED TO US CUSTOMERS OF (B)(4) KITS SEBIA MANUFACTURED. THE CUSTOMERS WERE REQUESTED TO COMPLETE A BOUNCE BACK NOTIFICATION ON THE NUMBER OF KITS INSPECTED AND IDENTIFY KIT(S) THAT WERE NO-COMPLIANT. THE ISSUE WAS LIMITED TO ONE KIT. THE ERROR WAS TRACED TO HUMAN ERROR IN PACKAGING AND CORRECTIVE MEASURES HAVE BEEN IMPLEMENTED WITH AN ADDITIONAL CONTROL STEP AT THE MANUFACTURING SITE.