ARCHITECT 6E44-21Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00380740009847), received between Dec 18, 2017 and Dec 5, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Cross Reactivity” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K050419); 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2022Low Test Results; Low Test Results

  ON (B)(6) 2022, THERMO FISHER SCIENTIFIC WAS INFORMED BY A DISTRIBUTOR THAT A PATIENT RECEIVING VANCOMYCIN SHOWED QUESTIONABLE LABORATORY RESULTS FOR DRUG MONITORING. A COMPLAINT WAS OPENED AND STATED THAT "THE PHYSICIAN BELIEVES THAT LEVEL COULD HAVE REACHED TOXICITY BECAUSE THE PATIENT STARTED TO HAVE TOXICITY SYMPTOMS AFTER THE LAST DOSE". ALL SAMPLES RUN ON THE VANCOMYCIN ASSAY REPORTED RESULTS OF < 1.1 UG/ML. IN THE LIMITATIONS OF THE PROCEDURE REPORTED IN THE IFU STATE THAT IN RARE CASES PATIENT SAMPLES MAY CONTAIN HETEROPHILE ANTIBODIES WHICH MAY PRODUCE LOW RESULTS WITH THE MULTIGENT VANCOMYCIN ASSAY. WHEN SAMPLES WERE ANALYZED USING A HETEROPHILE ANTIBODY BLOCKING TUBE, VALUES AS HIGH AS 52.1 UG/ML WERE REPORTED. THE THERAPEUTIC RANGE OF VANCOMYCIN IS 20-40 UG/ML. THIS INDICATES THAT THE PATIENT HAD HETEROPHILE ANTIBODIES PRESENT.

  Patient problems: Nausea; Tachycardia

  MAUDE report 15920265 ↗
• MalfunctionJun 15, 2018Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  IVD TEST FOR VANCOMYCIN FOR A TRANSPLANT PATIENT REVEALED UNUSUALLY LOW RESULT.

  Patient problems: No Information

  MAUDE report 7605896 ↗
• MalfunctionFeb 25, 2018Device Ingredient or Reagent Problem; Device Ingredient or Reagent Problem

  THE CUSTOMER BEGAN USING A NEW LOT OF VANCOMYCIN REAGENT LOT 71368FD01. PRIOR TO ACCEPTING THE USE OF THE NEW REAGENT LOT, THE CUSTOMER CALIBRATED AND RAN QC ALONG WITH SOME ARCHIVED PATENT SAMPLES TO CHECK THE PERFORMANCE. QC RESULTS WERE ALL IN RANGE WITH BOTH LOTS. THE CUSTOMER HAD A COUPLE OF LEFTOVER PATIENT SAMPLES WITH ORIGINAL VALUES (ON PREVIOUS REAGENT LOT 71346FD01) THAT WERE IN THE 31-34 UG/ML RANGE. THE CUSTOMER DECIDED TO RERUN LEFTOVER CUSTOMER SAMPLES IN PARALLEL ON THE NEW AND THE OLD REAGENT LOTS. CUSTOMER OBSERVED LOW RESULT OF <1.1UG/ML ONLY ON THE NEW REAGENT LOT. CUSTOMER DILUTED THE SAMPLE AND TESTED IT AGAIN ON THE NEW REAGENT LOT AND OBTAINED A RESULT OF 29 UG/ML CUSTOMER CONCLUDED THAT THE DISCREPANCY IS WITHIN THE PATIENT SAMPLE.

  Patient problems: No Patient Involvement

  MAUDE report 7295374 ↗
• MalfunctionDec 18, 2017Cross Reactivity; Cross Reactivity

  CUSTOMER REPORTED A DISCREPANT VANCOMYCIN PATIENT RESULT OF <1.1 ON A PATIENT WHO WAS RECEIVING VANCOMYCIN. IT WAS RETESTED ON OTHER ARCHITECT IN THE LAB AND THE RESULT WAS REPEATABLE, SAMPLE REPEATED IN 1:4 DILUTION AND READ 14.4. SAMPLE WAS ALIQUOTED AND SENT TO A REFERENCE LAB AND WAS TESTED BY THE SIEMENS VANCO ASSAY AND GOT A RESULT OF 32.0 NG/ML. THE PROBLEM STARTED ON (B)(6) 2017, CUSTOMER HAD 4 RANDOM DRAWS AND 2 DRAWS WERE DONE AFTER MEDICATION WAS GIVEN BETWEEN THE DATES (B)(6). THE SAME PATIENT DRAW FROM (B)(6) 2017 THE PATIENT RESULT WAS 16.4. NO ISSUES WITH OTHER ASSAYS QC ALL IN RANGE AND THE RETEST OF THE PROFICIENCY SAMPLE PRODUCED REPEATABLE RESULTS FROM THE ORIGINAL TESTING. CUSTOMER CONCLUDED THAT THE SAMPLE IS THE CAUSE OF THE PROBLEM.

  Patient problems: Toxemia

  MAUDE report 7124396 ↗
• MalfunctionDec 18, 2017Cross Reactivity; Cross Reactivity

  (B)(6). CUSTOMER IS NOT WILLING TO GIVE PATIENT INFORMATION OR IF TREATMENT WAS GIVEN. BOTH TUBES WERE PLASMA SPUN AT 10 MIN AT 5000 RPM. ON (B)(6) 2017 T19:16:43Z : CHATFAM : : NEW LOT OF CAL AND RTG BEING SENT IN FOR TROUBLE SHOOTING NCCHATFAM (B)(6) 2017 1420.

  Patient problems: Toxemia

  MAUDE report 7124389 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K050419. One submission often covers many models, so check the product and lot details in each record.

• Z-1102-2008 · Dec 20, 2007 · Terminated
  Seradyn QMS Vancomycin reagents, Part Number: 0373589. Seradyn, Inc, Indianapolis, IN.