Atellica CH Crea_2 11097596Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Creatinine Jaffe (Crea_2) Atellica CH - RGT 5888T · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 19
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00630414596457), received between Aug 24, 2022 and Nov 28, 2025 — classified as 19 malfunctions.
The most frequently reported specific device problem is “Low Test Results” (18 reports).
1 other recall cover devices cleared under the same FDA submission (K161494); 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Low Test Results18
- High Test Results1
Patient problems
- No Clinical Signs, Symptoms or Conditions19
Recent adverse event reports
The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 28, 2025Low Test Results; Low Test Results
THE CUSTOMER REPORTED THAT ERRONEOUSLY DEPRESSED CREATININE_2 (CREA_2) RESULTS WERE OBTAINED ON NINE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPROCESSED EITHER ON THE ORIGINAL ANALYZER OR ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE REPROCESSED RESULTS WERE HIGHER THAN THE ERRONEOUS RESULTS AND MATCHED THE PATIENT¿S CLINICAL PICTURE. THE REPROCESSED RESULTS WERE REPORTED AS THE CORRECT RESULTS TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED CREATININE_2 (CREA_2) RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23670401 ↗MalfunctionOct 15, 2025Low Test Results; Low Test Results
THE CUSTOMER REPORTED THAT THEY OBTAINED ERRONEOUSLY DEPRESSED CREATININE 2 (CREA 2) RESULTS ON SIXTEEN PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND WERE QUESTIONED. THE SAMPLES WERE REPEATED ON ALTERNATE ATELLICA CH 930 ANALYZERS. THE REPEAT RESULTS MATCHED THE PATIENT¿S CLINICAL HISTORY AND REPORTED TO THE PHYSICIAN(S) AS CORRECT RESULTS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23288377 ↗MalfunctionJul 4, 2025Low Test Results; Low Test Results
THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY DEPRESSED CREATININE_2 (CREA_2) PATIENT SAMPLE RESULT ON AN ATELLICA CH 930 ANALYZER. THE INITIAL ERRONEOUSLY DEPRESSED RESULT WAS REPORTED TO THE PHYSICIAN(S), AND THE RESULT WAS QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER. THE REPROCESSED RESULT RECOVERED HIGHER, MATCHED THE RESULT THAT WAS OBTAINED WHEN REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER, AND WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED CREATININE_2 (CREA_2) RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22402251 ↗MalfunctionJun 16, 2025Low Test Results; Low Test Results
THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY DEPRESSED CREATININE_2 (CREA_2) RESULTS ON TWENTY-THREE PATIENT SAMPLES ON AN ATELLICA CI 1900 ANALYZER. IT IS UNKNOWN WHETHER THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPEATED ON AN ALTERNATE ATELLICA CI 1900 ANALYZER. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THE CUSTOMER STATED THAT ROUGHLY HALF OF THE PATIENTS AFFECTED HAD DELAYED INFUSION TREATMENT BASED ON THE INITIAL RESULTS. THE CUSTOMER DID NOT PROVIDE THE SAMPLE IDS FOR WHICH THE INFUSION TREATMENT WAS DELAYED. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED CREATININE_2 (CREA_2) RESULTS AND THE DELAYED INFUSION TREATMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22210083 ↗MalfunctionMay 20, 2025Low Test Results; Low Test Results
THE CUSTOMER REPORTED TO SIEMENS THEY OBTAINED ERRONEOUSLY DEPRESSED (BELOW THE MEASURING INTERVAL) CREATININE_2 (CREA_2) PATIENT SAMPLE RESULTS ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED PATIENT. RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. HIGHER RESULTS OBTAINED, CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED CREATININE_2 (CREA_2) RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22053049 ↗MalfunctionMay 5, 2025Low Test Results; Low Test Results
THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED ERRONEOUSLY DEPRESSED CREATININE_2 (CREA_2) RESULTS ON THIRTY-SEVEN (37) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIAN AND WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED EITHER ON THE ORIGINAL OR ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE HIGHER REPROCESSED RESULTS WERE OBTAINED AND MATCHED THE PATIENT¿S CLINICAL HISTORY. THE REPROCESSED RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED CREATININE_2 (CREA_2) RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21959557 ↗MalfunctionApr 23, 2025Low Test Results; Low Test Results
THE CUSTOMER REPORTED TO SIEMENS THAT ERRONEOUSLY DEPRESSED CREATININE_2 (CREA_2) RESULTS WERE OBTAINED ON EIGHT (8) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE PATIENTS WERE UNDERGOING DIALYSIS, AND THE SAMPLES WERE DRAWN MONTHLY AS PART OF THEIR TREATMENT. NEW SAMPLES WERE DRAWN FROM THE SAME PATIENTS ON (B)(6) 2025 AND PROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER EXCEPT FOR THE SAMPLE IDENTIFIER: (B)(4). THE NEWLY DRAWN SAMPLE RESULTS WERE HIGHER THAN THE INITIAL RESULTS AND CONSISTENT WITH THE PATIENT¿S HISTORY. THE NEWLY DRAWN SAMPLE RESULTS WERE REPORTED TO THE PHYSICIAN(S). AFTER REVIEWING THE NEWLY DRAWN SAMPLE RESULTS, THE PHYSICIAN(S) QUESTIONED THE RESULTS FROM ON (B)(6) 2025. THE SAMPLES FROM ON (B)(6) 2025 WERE NOT REPROCESSED DUE TO THE DELAY IN QUESTIONING THE ERRONEOUS RESULTS. FOR SAMPLE IDENTIFIER: (B)(4), THE PATIENT DID NOT HAVE ANY SAMPLE DRAWS ON (B)(6) 2025, WHICH LED THE CUSTOMER TO PROVIDE THE PREVIOUSLY DRAWN CORRECT REPORTED RESULT FROM ON (B)(6) 2024 OBTAINED ON AN ALTERNATE ATELLICA CH 930 ANALYZER, WHICH WAS HIGHER THAN THE RESULT FROM ON (B)(6) 2025. NO CORRECTED REPORT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21888377 ↗MalfunctionMar 13, 2025Low Test Results; Low Test Results
THE CUSTOMER REPORTED TO SIEMENS THAT ERRONEOUSLY DEPRESSED CREATININE_2 (CREA_2) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. THE REPROCESSED RESULTS WERE REPORTED AS CORRECT RESULTS TO THE PHYSICIAN(S). OUT OF ALL THE PATIENTS, NEW SAMPLES WERE DRAWN FROM THE PATIENTS WITH SAMPLE IDENTIFIERS (B)(6). THE REDRAWN SAMPLES WITH SAMPLE IDENTIFIERS (B)(6) WERE PROCESSED ON THE ORIGINAL ANALYZER. THE REDRAWN SAMPLE WITH SAMPLE IDENTIFIER (B)(6) WAS PROCESSED ON AN ALTERNATE ATELLICA CH 930 ANALYZER. FOR SAMPLE IDENTIFIER (B)(6), NO CORRECT CREA_2 RESULT WAS OBTAINED, AND THE PATIENT WAS DISCHARGED ON (B)(6) 2025. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED CREA_2 RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21594062 ↗MalfunctionMar 6, 2025Low Test Results; Low Test Results
THE CUSTOMER REPORTED TO SIEMENS THAT ERRONEOUSLY DEPRESSED CREATININE_2 (CREA_2) RESULTS WERE OBTAINED ON TWENTY-TWO (22) PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER. THE ERRONEOUSLY DEPRESSED RESULTS WERE REPORTED TO THE PHYSICIAN(S), AND THE RESULTS WERE NOT QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER. HIGHER REPROCESSED RESULTS WERE OBTAINED AND CONSIDERED CORRECT. CORRECTED REPORTS WERE ISSUED. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED CREATININE_2 (CREA_2) RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21534665 ↗MalfunctionOct 10, 2024High Test Results; High Test Results
THE CUSTOMER REPORTED ERRONEOUSLY ELEVATED CREATININE_2 (CREA_2) PATIENT SAMPLE RESULTS ON AN ATELLICA ® CH 930 ANALYZER. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S) AND SOME WERE QUESTIONED. THE SAME SAMPLES WERE REPROCESSED ON AN ALTERNATE ANALYZER. THE LOWER REPROCESSED RESULTS OBTAINED WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THE CUSTOMER STATED THAT (4) FOUR PATIENTS WERE SENT TO THE HOSPITAL BUT DID NOT HAVE ANY DETAILS TO PROVIDE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY ELEVATED CREATININE_2 (CREA_2) RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20420295 ↗MalfunctionJun 19, 2024Low Test Results; Low Test Results
THE CUSTOMER REPORTED TO SIEMENS THAT THEY OBTAINED AN ERRONEOUSLY DEPRESSED CREATININE_2 (CREA_2) PATIENT SAMPLE RESULT ON AN ATELLICA CH 930 ANALYZER. THE INITIAL ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPROCESSED ON THE ORIGINAL ATELLICA CH 930 ANALYZER. THE REPROCESSED RESULT RECOVERED HIGHER, MATCHED THE CLINICAL HISTORY AND WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ERRONEOUSLY DEPRESSED CREATININE_2 (CREA_2) RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19566091 ↗MalfunctionMar 11, 2024Low Test Results; Low Test Results
A FALSELY DEPRESSED CREATININE_2 (CREA_2) PATIENT SAMPLE RESULT WAS OBTAINED ON AN ATELLICA ® CH 930 ANALYZER COMPARED TO REPEAT TESTING. THE FALSELY DEPRESSED PATIENT RESULT WAS REPORTED TO THE PHYSICIAN AND QUESTIONED. THE SAME SAMPLE WAS REPROCESSED ON THE SAME ATELLICA ® CH 930 ANALYZER. ON 27-FEB-2024 THE SAME SAMPLE WAS REPROCESSED ON AN ALTERNATE ATELLICA ® CH 930 ANALYZER AND RESULTED HIGHER. THE HIGHER RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CREATININE_2 (CREA_2) RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18875044 ↗MalfunctionJul 10, 2023Low Test Results; Low Test Results
THE CUSTOMER OBTAINED A FALSELY DEPRESSED CREATININE_2 (CREA_2) RESULT ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER, SERIAL NUMBER (S/N): (B)(6). THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE SAMPLE WAS RETESTED, AND A HIGHER RESULT WAS OBTAINED. THE RETEST RESULT WAS REPORTED AS THE CORRECT RESULT TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO FALSELY DEPRESSED CREA_2 RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17287244 ↗MalfunctionJun 30, 2023Low Test Results; Low Test Results
THE CUSTOMER REPORTED A FALSELY DEPRESSED CREATININE_2 (CREA_2) RESULT ON A MALE PATIENT SAMPLE ON A ATELLICA CH 930 ANALYZER. THE INITIAL ERRONEOUS RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME ATELLICA CH ANALYZER. THE REPEAT RESULT WAS HIGHER THAN THE ERRONEOUS RESULT. THE REPEAT RESULT WAS CONSIDERED AS THE CORRECT RESULT BY THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CREATININE_2 RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17238020 ↗MalfunctionMay 24, 2023Low Test Results; Low Test Results
LOW-LEVEL QUALITY CONTROL (QC) AND FALSELY DEPRESSED CREATININE_2 (CREA_2) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER, S/N: (B)(6). THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT. THE REPEAT RESULTS WERE HIGHER THAN THE INITIAL ERRONEOUS RESULTS AND MATCHED PATIENT HISTORY. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE CUSTOMER CONFIRMED THAT THERE WAS NO HARM TO THE PATIENTS AND NO DELAY IN TESTING DUE TO THE EVENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO LOW-LEVEL QC AND FALSELY DEPRESSED CREA_2 RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16991165 ↗MalfunctionMay 24, 2023Low Test Results; Low Test Results
LOW-LEVEL QUALITY CONTROL (QC) AND FALSELY DEPRESSED CREATININE_2 (CREA_2) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER, S/N: CM03271. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT. THE REPEAT RESULTS WERE HIGHER THAN THE INITIAL ERRONEOUS RESULTS AND MATCHED PATIENT HISTORY. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE CUSTOMER CONFIRMED THAT THERE WAS NO HARM TO THE PATIENTS AND NO DELAY IN TESTING DUE TO THE EVENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO LOW-LEVEL QC AND FALSELY DEPRESSED CREA_2 RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16991159 ↗MalfunctionMay 24, 2023Low Test Results; Low Test Results
LOW-LEVEL QUALITY CONTROL (QC) AND FALSELY DEPRESSED CREATININE_2 (CREA_2) RESULTS WERE OBTAINED ON MULTIPLE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER, S/N: CM03271. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT. THE REPEAT RESULTS WERE HIGHER THAN THE INITIAL ERRONEOUS RESULTS AND MATCHED PATIENT HISTORY. THE REPEAT RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THE CUSTOMER CONFIRMED THAT THERE WAS NO HARM TO THE PATIENTS AND NO DELAY IN TESTING DUE TO THE EVENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO LOW-LEVEL QC AND FALSELY DEPRESSED CREA_2 RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16991146 ↗MalfunctionApr 13, 2023Low Test Results; Low Test Results
THE CUSTOMER OBSERVED FALSELY DEPRESSED CREATININE_2 (CREA_2) RESULTS ON SIX PATIENT SAMPLES ON AN ATELLICA CH ANALYSER, LOT 221736. THE ERRONEOUS RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE RESULTS WERE NOT QUESTIONED BY THE PHYSICIAN(S). THE SAMPLES WERE REPROCESSED ON AN ORIGINAL INSTRUMENT. THE REPEAT RESULTS WERE HIGHER THAN THE INITIAL RESULTS. THE REPEAT RESULTS WERE CONSIDERED AS CORRECT RESULTS BY THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY DEPRESSED CREA_2 RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16732806 ↗MalfunctionAug 24, 2022Low Test Results; Low Test Results
THREE DISCORDANT, FALSELY LOW CREATININE_2 (CREA_2) RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES ON AN ATELLICA CH 930 ANALYZER USING ATELLICA CH CREATININE_2 REAGENT. THE DISCORDANT PATIENT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME SYSTEM AFTER CHANGING THE REAGENT PACK, RECOVERING HIGHER. THE HIGHER RESULTS WERE REPORTED, AS THE CORRECT RESULTS, TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CREA_2 RESULTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15287278 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K161494. One submission often covers many models, so check the product and lot details in each record.
- Z-2431-2020 · Jun 5, 2020 · TerminatedAtellica CH Chemistry Calibrator
Other ALKALINE PICRATE, COLORIMETRY, CREATININE devices
- Dimension® Flex® reagent cartridge CRE2 10872079Siemens Healthcare Diagnostics Inc. · ALKALINE PICRATE, COLORIMETRY, CREATININE1 recall9 reports
- ABX PENTRA CREATININE 120 CP 1220001933Horiba Abx Sas · Alkaline Picrate, Colorimetry, Creatinine1 recall0 reports
- ARCHITECT 3L81-22Abbott Laboratories · ALKALINE PICRATE, COLORIMETRY, CREATININE31 reports
- Alinity 07P9920Abbott GmbH · ALKALINE PICRATE, COLORIMETRY, CREATININE24 reports
- Creatinine Jaffe Gen.2 08057532190Roche Diagnostics GmbH · ALKALINE PICRATE, COLORIMETRY, CREATININE17 reports
- Alinity 04T9120Abbott Ireland · ALKALINE PICRATE, COLORIMETRY, CREATININE15 reports
- Alinity 07P9930Abbott GmbH · ALKALINE PICRATE, COLORIMETRY, CREATININE15 reports
- ARCHITECT 3L81-32Abbott Laboratories · ALKALINE PICRATE, COLORIMETRY, CREATININE15 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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