ARCHITECT 7K61-37Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380740014193), received between Dec 5, 2020 and Nov 4, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “High Test Results” (4 reports).

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2024High Test Results; High Test Results

  THE CUSTOMER REPORTED DOCTORS QUESTIONING FALSELY HIGH ARCHITECT VITAMIN B12 RESULTS FOR MULTIPLE PATIENT SAMPLES. THE CUSTOMER STATED HIGH RESULTS OF > 2000 PG/ML WERE BEING GENERATED ACROSS 2 OF THEIR ANALYZERS. THE CUSTOMER SENT THE SAMPLES OUT TO ANOTHER LAB (REFERENCE LAB) AND THE B12 RESULT OF ONE SAMPLE CAME BACK AS 285 PG/ML. THE CUSTOMER¿S REFERENCE RANGE FOR B12 IS 213-816 PG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20600937 ↗
• MalfunctionJun 14, 2023High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ARCHITECT B12 RESULT FOR ONE PATIENT WHEN RUNNING ON THE ARCHITECT I2000SR ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6): INITIAL B12 RESULT = 480 PG/ML; REPEAT B12 RESULTS = 265 AND 256 PG/ML THE CUSTOMER'S PROCEDURE IS TO REPEAT SAMPLES W/ RESULTS > 315 PG/ML (NORMAL REFERENCE RANGE IS 300-2000 PG/ML). THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17132158 ↗
• MalfunctionJan 6, 2022High Test Results; High Test Results

  THE CUSTOMER REPORTED A FALSELY ELEVATED ARCHITECT B12 RESULT ON A PATIENT. RESULTS PROVIDED: (B)(6) 2021, SID (B)(6)= 364 PG/ML< REPEATED ON (B)(6) 2021 = 274 PG/ML (BOTH RESULTS USING LOT# 23108UI00). NORMAL RANGE: 345-1485 PG/ML. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13176978 ↗
• MalfunctionDec 5, 2020High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ARCHITECT B12 RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 211-911 PG/ML): PATIENT # INITIAL RESULT, ON (B)(6) 2020, WAS 240, REPEATS WERE 197 AND 160 PG/ML. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10951364 ↗