ALINITY I B12 REAGENT KIT

Additional Manufacturer Narrative

DATA AND INFORMATION PROVIDED BY THE CUSTOMER CONFIRMS THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE IDENTIFIED. THE TICKET SEARCH BY LOT NUMBER INDICATES THE PRODUCT LOT IS PERFORMING AS EXPECTED. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON LOT 41679UD00, WHICH DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE PRODUCT FOR THE ISSUE. REVIEW OF FIELD DATA FOR THE ALINITY I VITAMINB12 ASSAYS SHOWS THAT THE MEDIAN PATIENT RESULT FOR LOT 41679UD00 FALLS WITHIN 1SD OF THE ESTABLISHED BASELINE, INDICATING THE REAGENT LOT IS PERFORMING ACCEPTABLY ON MARKET. A REVIEW OF THE LABELING ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT ANTI-HCV REAGENT WAS IDENTIFIED.CORRECTED INFORMATION FOR SECTION B5: THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I B12 RESULTS FOR ONE PATIENT THAT REQUIRED CORRECTED REPORTS. ADDITIONALLY, THE CUSTOMER NOTED THAT CONTROLS WERE OUT OF SPECIFICATION. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER REFERENCE RANGE IS 153 TO 755 PMOL/L): SAMPLE ID (B)(6) RELEASED RESULT 237 PMOL/L, CORRECTED RESULT 141.0 PMOL/L, SAMPLE ID (B)(6) RELEASED RESULT 271.600 PMOL/L, CORRECTED RESULT 192.5 PMOL/L, SAMPLE ID (B)(6) RELEASED RESULT 247.4 PMOL/L, CORRECTED RESULT 190 MMOL/L, SAMPLE ID (B)(6) RELEASED RESULT 245.8 PMOL/L, CORRECTED RESULT 164.8 PMOL/L, SAMPLE ID (B)(6) RELEASED RESULT 241 PMOL/L, CORRECTED RESULT 182 PMOL/L, SAMPLE ID (B)(6) RELEASED RESULT 274 PMOL/L, CORRECTED RESULT 195 PMOL/L, SAMPLE ID (B)(6) RELEASED RESULT 291 PMOL/L, CORRECTED RESULT 221 PMOL/L, SAMPLE ID (B)(6) RELEASED RESULT 314 PMOL/L, CORRECTED RESULT 219 PMOL/L.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I B12 RESULTS FOR ONE PATIENT THAT REQUIRED CORRECTED REPORTS. ADDITIONALLY, THE CUSTOMER NOTED THAT CONTROLS WERE OUT OF SPECIFICATION. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER REFERENCE RANGE IS 153 TO 755 PMOL/L): SAMPLE ID (B)(6) RELEASED RESULT 237 PMOL/L, CORRECTED RESULT 141.0 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

Additional Manufacturer Narrative

COMPLETE INFORMATION FROM PATIENT IDENTIFIER: SID (B)(6). AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Additional Manufacturer Narrative

AFTER FURTHER REVIEW, IT WAS DISCOVERED THAT THERE WAS AN ERROR IN THE MANUFACTURER NARRATIVE SECTION IN REPORT REF # 3005094123-2022-00304-01. THIS REPORT CORRECTS THE ERROR FOUND IN H11 ADDITIONAL MFG NARRATIVE. IT CHANGED FROM ' BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ARCHITECT ANTI-HCV REAGENT WAS IDENTIFIED' TO 'BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I VITAMIN B12 REAGENT WAS IDENTIFIED'. THE FOLLOWING FIELDS IN THIS REPORT WERE ALSO UPDATED: D4 PRIMARY UDI NUMBER, G1 CONTACT OFFICE ADDRESS 1, CONTACT OFFICE CITY, CONTACT OFFICE COUNTRY, CONTACT OFFICE FIRST NAME, CONTACT OFFICE LAST NAME, CONTACT OFFICE EMAIL, CONTACT OFFICE PHONE NUMBER, CONTACT OFFICE FAX NUMBER, DATA AND INFORMATION PROVIDED BY THE CUSTOMER CONFIRMS THE COMPLAINT ISSUE WITHOUT INDICATION FOR ANY ADDITIONAL ISSUE IDENTIFIED. THE TICKET SEARCH BY LOT NUMBER INDICATES THE PRODUCT LOT IS PERFORMING AS EXPECTED. RETURN TESTING WAS NOT PERFORMED AS RETURNS WERE NOT AVAILABLE. DEVICE HISTORY RECORD REVIEW WAS PERFORMED ON LOT 41679UD00, WHICH DID NOT SHOW ANY POTENTIAL NON-CONFORMANCES, DEVIATIONS, OR NON-CONFORMANCES. TRENDING REVIEW DID NOT IDENTIFY ANY TRENDS FOR THE PRODUCT FOR THE ISSUE. REVIEW OF FIELD DATA FOR THE ALINITY I VITAMINB12 ASSAYS SHOWS THAT THE MEDIAN PATIENT RESULT FOR LOT 41679UD00 FALLS WITHIN 1SD OF THE ESTABLISHED BASELINE, INDICATING THE REAGENT LOT IS PERFORMING ACCEPTABLY ON MARKET. A REVIEW OF THE LABELING ADDRESSES THE CUSTOMER'S ISSUE. BASED ON THE INVESTIGATION, NO SYSTEMIC ISSUE OR DEFICIENCY OF THE ALINITY I VITAMIN B12 REAGENT WAS IDENTIFIED. ADDITIONAL INFORMATION FOR SECTION B5: THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I B12 RESULTS FOR ONE PATIENT THAT REQUIRED CORRECTED REPORTS. ADDITIONALLY, THE CUSTOMER NOTED THAT CONTROLS WERE OUT OF SPECIFICATION. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER REFERENCE RANGE IS 153 TO 755 PMOL/L): SAMPLE ID (B)(6) RELEASED RESULT 237 PMOL/L, CORRECTED RESULT 141.0 PMOL/L SAMPLE ID (B)(6) RELEASED RESULT 271.600 PMOL/L, CORRECTED RESULT 192.5 PMOL/L SAMPLE ID (B)(6) RELEASED RESULT 247.4 PMOL/L, CORRECTED RESULT 190 MMOL/L SAMPLE ID (B)(6) RELEASED RESULT 245.8 PMOL/L, CORRECTED RESULT 164.8 PMOL/L SAMPLE ID (B)(6) RELEASED RESULT 241 PMOL/L, CORRECTED RESULT 182 PMOL/L SAMPLE ID (B)(6) RELEASED RESULT 274 PMOL/L, CORRECTED RESULT 195 PMOL/L SAMPLE ID (B)(6) RELEASED RESULT 291 PMOL/L, CORRECTED RESULT 221 PMOL/L SAMPLE ID (B)(6) RELEASED RESULT 314 PMOL/L, CORRECTED RESULT 219 PMOL/L.

Description of Event or Problem

THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY I B12 RESULTS FOR ONE PATIENT THAT REQUIRED CORRECTED REPORTS. ADDITIONALLY, THE CUSTOMER NOTED THAT CONTROLS WERE OUT OF SPECIFICATION. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER REFERENCE RANGE IS 153 TO 755 PMOL/L): SAMPLE ID (B)(6) RELEASED RESULT 237 PMOL/L, CORRECTED RESULT 141.0 PMOL/L. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.