ARCHITECT 6L27-25Recalls & reported problems

Summary

The FDA's MAUDE database contains 111 adverse event reports that list this exact device (DI 00380740011185), received between Nov 9, 2016 and Mar 4, 2024 — classified as 111 malfunctions.

The most frequently reported specific device problem is “High Test Results” (88 reports).

1 FDA recall record name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K113704); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 9, 2020Terminated

   An erroneous concentration value for hepatitis A virus was utilized during manufacture, leading to a decreased amount of antigen used for the impacted lots.

   Z-1728-2020 · Root cause: Mixed-up of materials/components · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 111 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2024False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE REACTIVE ARCHITECT HAVAB-G RESULT FOR ONE PATIENT. THE CUSTOMER STATED THERE HAS BEEN AN INCREASE IN POSITIVITY RATES WHEN SWITCHING TO THIS LOT OF REAGENT. THE FOLLOWING EXAMPLE WAS PROVIDED (<1.00 S/CO IS NONREACTIVE, >/=1.00 S/CO IS REACTIVE): INITIAL RESULT, WITH ONE TUBE FROM THE PATIENT ON 13DEC23, WAS 0.51, REPEAT, WITH A SECONDARY TUBE FROM THE PATIENT, WAS 1.04 S/CO. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18833292 ↗
• MalfunctionNov 22, 2022False Positive Result; False Positive Result

  THE CUSTOMER STATED THAT A FALSE REACTIVE ARCHITECT HAVAB-G RESULT WAS GENERATED FOR A PATIENT SAMPLE ON (B)(6) 2022. THE SAMPLE INITIALLY TESTED NONREACTIVE AT 0.03 S/CO. THE SAMPLE RETESTED REACTIVE AT 1.01 S/CO TWO DAYS LATER ON A DIFFERENT ARCHITECT ANALYZER. THE FALSE REACTIVE RESULT WAS NOT REPORTED OUT OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15847388 ↗
• MalfunctionJul 15, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A FALSE REACTIVE ARCHITECT HAVAB-G RESULT FOR A PATIENT SAMPLE WHILE RUNNING ON THE ARCHITECT I1000SR ANALYZER. THE NEGATIVE CONTROL WAS RUNNING HIGHER THAN THE PEER GROUP BUT WAS STILL IN RANGE. THE CUSTOMER PULLED PATIENT SAMPLES TO REPEAT THAT HAD VALUES CLOSE TO THE CUTOFF AND HAD ONE DISCREPANT RESULT THAT WENT FROM REACTIVE TO NONREACTIVE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: < 1.00 S/CO IS NONREACTIVE, >/= 1.00 S/CO IS REACTIVE): SID (B)(6) TESTED ON (B)(6) 2022. INITIAL RESULT: 1.13 S/CO (REACTIVE ON LOT 29510BE00); REPEAT ON NEW LOT 35328BE00: 0.94 S/CO (NONREACTIVE) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15026460 ↗
• MalfunctionJun 10, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT HAVAB-G RESULTS WHICH QUESTIONED BY PHYSICIAN AND DOES NOT CORRELATE WITH PATIENT HISTORY ON MULTIPLE PATIENTS. THE RESULTS PROVIDED WERE: SID (B)(6) = 1.46 S/CO (> OR = 1.00 S/CO=REACTIVE), SID (B)(6) = 1.25 S/CO, SID (B)(6) = 1.27 S/CO THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14654408 ↗
• MalfunctionFeb 14, 2022False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED A (B)(6) ARCHITECT HAVAB-G RESULT FOR ONE PATIENT. THE INITIAL ARCHITECT HAVAB-G RESULT WAS (B)(6) REPEATED ON ANOTHER INSTRUMENT AND THE RESULT WAS (B)(6) NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13525428 ↗
• MalfunctionJul 28, 2020False Positive Result; False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ARCHITECT (B)(6) RESULTS ON MULTIPLE PATIENTS. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: < 1.0 S/CO = NONREACTIVE, >= 1.00 S/CO = REACTIVE): PATIENT #1 = 1.05 S/CO (OLD), 0.31 S/CO (NEW); PATIENT #2 = 1.09 S/CO (OLD), 0.62 S/CO (NEW); PATIENT #3 = 1.52 S/CO (OLD), 0.62 S/CO (NEW); PATIENT #4 = 1.19 S/CO (OLD), 0.39 S/CO (NEW); PATIENT #5 = 1.05 S/CO (OLD), 0.30 S/CO (NEW); PATIENT #6 = 1.61 S/CO (OLD), 0.48 S/CO (NEW); PATIENT #7 = 1.56 S/CO (OLD), 0.53 S/CO (NEW). THE INITIAL (B)(6) RESULTS WITH THE OLD LOT ARE REACTIVE, REPEAT RESULTS USING THE NEW LOT ARE NONREACTIVE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10335032 ↗
• MalfunctionJul 20, 2020False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT (B)(6) RESULTS FOR 1 PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2020 SID (B)(6) INITIAL RESULT = 2.36 S/CO (REACTIVE), REPEAT = 2.29 S/CO (REACTIVE). NEW DRAW SPECIMEN: ON (B)(6) 2020 SID (B)(6) INITIAL RESULT 0.93 S/CO (NONREACTIVE), REPEAT = 0.83 S/CO (NONREACTIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10298644 ↗
• MalfunctionJun 18, 2020False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED (B)(6) ARCHITECT (B)(6) RESULTS ON 2 PATIENTS. PATIENT #1 GENERATED A RESULT OF (B)(6), REPEAT (B)(6). PATIENT #2 GENERATED A RESULT OF (B)(6), REPEAT (B)(6). THE REFERENCE RANGE FOR (B)(6) IS (B)(6) AND (B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10170219 ↗
• MalfunctionMay 27, 2020False Positive Result; False Positive Result

  WHILE RUNNING A COMPARATIVE STUDY BETWEEN LOTS, THE CUSTOMER REPORTED (B)(6) ARCHITECT HAVAB-G ASSAY RESULTS FOR FOUR PATIENTS ON THE CURRENT LOT 12026BE00, WHICH WAS USED FOR INDIVIDUAL PATIENT MANAGEMENT. THE CUSTOMER PROVIDED: (B)(6) INITIAL = (B)(6); (B)(6) INITIAL = (B)(6); (B)(6) INITIAL = (B)(6); (B)(6) INITIAL = (B)(6). (RANGES: (B)(6)). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10093083 ↗
• MalfunctionMay 26, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED (B)(6) CONTROL WAS OUT OF RANGE HIGH AND SHIFTED HIGH WHILE USING THE ARCHITECT HAVAB-G REAGENT. THE CUSTOMER STATED THE ORIGINAL RUN OF (B)(6) QUALITY CONTROL GENERATED A RESULT OF (B)(4) AND REPEATED AT (B)(4). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10086634 ↗
• MalfunctionMay 18, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED DISCREPANT ARCHITECT HAVAB-G RESULTS FOR A PATIENT WHEN PERFORMING A CORRELATION/VALIDATION STUDY TO THE ADVIA METHODOLOGY. SID (B)(6) GENERATED A RESULT OF (B)(6), THAT WAS (B)(6) VIA THE ADVIA METHOD. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10066626 ↗
• MalfunctionMay 18, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED (B)(6) ARCHITECT HAVAB-G RESULTS DURING VALIDATION STUDY WHEN PROCESSING ON THE ARCHITECT I2000SR THAT WAS NOT BEING USED FOR PATIENT MANAGEMENT. THE CUSTOMER REPORTED THAT SID (B)(6) GENERATED A RESULT OF (B)(6) VIA THE ADVIA METHOD. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10066522 ↗
• MalfunctionMay 8, 2020False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED (B)(6) ARCHITECT HAVAB-G RESULTS ON ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: ON (B)(6) 2020, INITIAL RESULT WAS (B)(6), REPEAT WAS (B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10040196 ↗
• MalfunctionApr 27, 2020False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT (B)(6) RESULTS FOR 3 SAMPLES. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE = S/CO): (B)(6) 2020 SID (B)(6) INITIAL RESULT = 1.33 (REACTIVE), REPEAT WITH NEW LOT NUMBER = 0.43 (NONREACTIVE); (B)(6) 2020 SID (B)(6) INITIAL RESULT = 2.36 (REACTIVE), REPEAT WITH NEW LOT NUMBER = 0.83 (NONREACTIVE); (B)(6) 2020 SID (B)(6) INITIAL RESULT = 1.02 (REACTIVE), REPEAT WITH NEW LOT NUMBER = 0.45 (NONREACTIVE). THE CUSTOMER REPORTED FAILED VALIDATION STUDY SAMPLES WHEN STARTING A NEW LOT OF ARCHITECT (B)(6) ASSAY. ADDITIONAL DATA WAS PROVIDED FOR TROUBLESHOOTING PURPOSES ONLY. THE RESULTS OF THE VALIDATION STUDY PROMPTED THE CUSTOMER TO PERFORM REPEAT TESTING ON THE SIDS ABOVE. THE INITIAL REACTIVE RESULTS WERE REPORTED OUT OF THE LABORATORY AND CORRECTED TO NONREACTIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10002534 ↗
• MalfunctionApr 10, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT THE NEGATIVE CONTROL WAS AT THE UPPER LIMIT AND OUT OF RANGE HIGH WHILE USING THE ARCHITECT HAVAG-B REAGENT. THE CUSTOMER PROVIDED THE FOLLOWING DATA: NEG CONTROL=0.68/0.65 (RANGE=</=0.65). THE CUSTOMER WAS NOT ABLE TO CONFIRM WHICH HAVAB-G REAGENT LOT WAS BEING USED. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9949221 ↗
• MalfunctionApr 8, 2020False Positive Result; False Positive Result

  THE CUSTOMER OBSERVED FALSE REACTIVE ARCHITECT HAVAB-G RESULTS FOR 1 SAMPLE. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE = S/CO): INITIAL RESULT = 1.01 (REACTIVE), REPEAT = 0.93 (NONREACTIVE). THE CUSTOMER REPORTED NON-CONSENSUS ON CAP STUDY SAMPLES. UPON FURTHER REVIEW, THE CUSTOMER NOTED THAT THE REAGENT LOT NUMBER USED IS PART OF THE FA09MAR2020 RECALL LETTER THAT THEY RECEIVED. ADDITIONAL DATA WAS PROVIDED FOR TROUBLESHOOTING PURPOSES ONLY. THE RESULTS OF THE CAP SAMPLES PROMPTED THE CUSTOMER TO PERFORM REPEAT TESTING ON PATIENT SAMPLES WITH INITIAL RESULTS THAT WERE GENERATED ON THE LOT IMPACTED BY THE RECALL. THE INITIAL REACTIVE RESULT THAT WAS REPORTED OUT OF THE LABORATORY AND CORRECTED TO NONREACTIVE. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9937796 ↗
• MalfunctionApr 6, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT SINCE SWITCHING TO A NEW LOT OF THE ARCHITECT HAVAB-G REAGENT, THEIR QUALITY CONTROL HAS SHIFTED HIGH AND THE (B)(6) GENERATED (B)(6) RESULTS. THE CUSTOMER PERFORMED A 5-PATIENT CORRELATION STUDY AND ALL RESULTS WERE HIGHER WITH THE NEW LOT. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9928930 ↗
• MalfunctionApr 6, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED THE NEGATIVE CONTROLS ARE SHIFTING HIGH WHILE USING THE ARCHITECT HAVAB-G REAGENT. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9928755 ↗
• MalfunctionApr 6, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT THE BIORAD VIROCLEAR CONTROLS WERE TRENDING UP AND NOW OUT OF RANGE HIGH WHILE USING THE ARCHITECT HAVAB-G REAGENT. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9928400 ↗
• MalfunctionApr 6, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT THE NEGATIVE QUALITY CONTROLS WERE SHIFTING HIGH WHEN USING THE ARCHITECT HAVAB-G REAGENT. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9928318 ↗
• MalfunctionApr 6, 2020High Test Results; High Test Results

  THE CUSTOMER REPORTED THAT THE NEGATIVE QUALITY CONTROLS WERE SHIFTING HIGH WHEN USING THE ARCHITECT HAVAB-G REAGENT. THE CUSTOMER STATED THAT THE (B)(6) CONTROLS WAS GENERATING RESULTS OF (B)(6). THERE WAS NO PATIENT INVOLVEMENT AND NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9928192 ↗
• MalfunctionApr 6, 2020False Positive Result; False Positive Result

  THE CUSTOMER PERFORMED A LOOK BACK AT RESULTS AND IDENTIFIED APPROXIMATELY 33 PATIENT CAP SAMPLES THAT FELL INTO THE RANGE OF (B)(6). THE RESULTS WERE NOT BEING USED FOR PATIENT MANAGEMENT AND THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9928098 ↗
• MalfunctionApr 5, 2020False Positive Result; False Positive Result

  THE ACCOUNT STATED FALSE REACTIVE ARCHITECT HAVAB-G RESULTS WERE GENERATED ON SAMPLES THAT HAD ANTI-HCV HIGH VIRAL LOADS. ARCHITECT HAVAB-G REACTIVE VALUES OF 1.73 TO 3.5 S/CO WERE GENERATED ON SAMPLES THAT TESTED SIEMENS CENTAUR HAVAB TOTAL NEGATIVE. NO SPECIFIC PATIENT INFORMATION OR DATA WILL BE PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9927092 ↗
• MalfunctionApr 3, 2020False Positive Result; False Positive Result

  THE CUSTOMER REPORTED A FALSE REACTIVE ARCHITECT HAVAB-G RESULT ON ONE PATIENT WHILE USING A LOT ASSOCIATED WITH FA09MAR2020. THE RESULTS PROVIDED WERE: IMPACTED LOT = 1.07S/CO (>/= 1.00S/CO = REACTIVE). AFTER RECEIVING FA09MAR2020, THE CUSTOMER RETESTED THE SAMPLE WITH LOT 12026BE00 AND THE RESULT = 0.83S/CO (<1.00S/CO = NONREACTIVE). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9921787 ↗
• MalfunctionApr 3, 2020False Positive Result; False Positive Result

  THE CUSTOMER WAS PERFORMING A LOOKBACK OF RESULTS AND REPORTED (B)(6) ARCHITECT HAVAB-G RESULTS WERE GENERATED FOR A PATIENT. THE CUSTOMER STATED THAT SID (B)(6) GENERATED A RESULT OF (B)(6) WITH THE ARCHITECT HAVAB-G REAGENT LOT 06172BE00. WHEN REPEATED WITH THE CMIA METHOD, THE SAMPLE GENERATED A RESULT OF (B)(6). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9921323 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113704. One submission often covers many models, so check the product and lot details in each record.

• Z-0574-2020 · Nov 7, 2019 · Terminated
  ARCHITECT HAVAB-G Calibrator, REF 6L27-01