Atellica CH Reaction Ring Segment 11099326Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 00630414596143), received between Oct 28, 2019 and Nov 1, 2024 — classified as 23 malfunctions.

The most frequently reported specific device problem is “High Test Results” (19 reports).

1 FDA recall record name this device's identifier, 1 still open.

7 other recalls cover devices cleared under the same FDA submission (K161954); 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.

Recalls naming this device

1. Oct 21, 2024Class IIOpen, Classified

   A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the cuvette segment have a potential for imprecision and erroneously depressed or elevated QC and patient results for seven (7) analytes: Ammonia, Acetaminophen, Alanine Aminotransferase (ALT), Hemoglobin A1c, Creatinine Kinase (CK), Cystatin C, and Salicylate.

   Z-0496-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 1, 2024Imprecision; Imprecision

  THE CUSTOMER REPORTED QUALITY CONTROL (QC) IMPRECISION FOR THE SALICYLATE (SAL) ASSAY ON THE ATELLICA CH 930 ANALYZER. THE CUSTOMER STATED THAT NO PATIENT SAMPLES WERE REPORTED WHILE THE QUALITY CONTROL (QC) WAS OUT OF RANGE. NO PATIENT RESULTS WERE IMPACTED OR REPORTED. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THE OBSERVED IMPRECISION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20586379 ↗
• MalfunctionOct 28, 2020Low Test Results; Low Test Results

  A DISCORDANT, FALSELY DEPRESSED CALCIUM_2 (CA_2) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON AN ATELLICA CH 930 ANALYZER. A DEPRESSED GLUCOSE HEXOKINASE 3 (GLUH_3) RESULT WAS OBTAINED ON ANOTHER PATIENT SAMPLE AND A DISCORDANT, FALSELY DEPRESSED ALBUMIN (ALB) RESULT WAS OBTAINED ON A THIRD PATIENT SAMPLE ON THE SAME ANALYZER. THE FALSELY DEPRESSED RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON THE SAME INSTRUMENT AND THE REPEAT RESULTS WERE HIGHER THAN THE DISCORDANT RESULTS. THE REPEAT 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 RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10749375 ↗
• MalfunctionMar 17, 2020Low Test Results; Low Test Results

  ONE DISCORDANT, FALSELY DEPRESSED CALCIUM_2 (CA_2) RESULT WAS OBTAINED ON A SINGLE PATIENT USING ATELLICA® CH 930 MODULE. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED USING THE SAME ATELLICA® CH 930 MODULE. THE REPEAT RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS UNNECESSARILY HOSPITALIZED DUE TO THE INITIAL FALSELY DEPRESSED CA_2 RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED CA_2 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9838733 ↗
• MalfunctionMar 16, 2020High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON ATELLICA CH 930 MODULE. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAMPLE WAS REPEATED USING THE SAME ATELLICA CH 930 MODULE. THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9836736 ↗
• MalfunctionMar 16, 2020High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON ATELLICA CH 930 MODULE. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S) AND WAS QUESTIONED. THE SAMPLE WAS REPEATED USING THE SAME ATELLICA CH 930 MODULE. THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9836731 ↗
• MalfunctionMar 2, 2020Low Test Results; Low Test Results

  ONE DISCORDANT, FALSELY DEPRESSED CALCIUM_2 (CA_2) RESULT WAS OBTAINED ON A SINGLE PATIENT USING ATELLICA® CH 930 MODULE. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED 3 TIMES USING AN ALTERNATE ATELLICA® CH 930 MODULE. THE FIRST REPEAT RESULT WAS CONSIDERED CORRECT AND WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY DEPRESSED CA_2 RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9775749 ↗
• MalfunctionDec 26, 2019High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED USING THE ANOTHER ATELLICA CH 930 ANALYZER (SERIAL NUMBER (B)(4)). THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THE CUSTOMER DECLINED TO PROVIDE THE CORRECT RESULTS FOR ASSESSMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9521644 ↗
• MalfunctionDec 26, 2019High Test Results; High Test Results

  SEVEN DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON ATELLICA CH 930 ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED USING THE ANOTHER ATELLICA CH 930 ANALYZER (SERIAL NUMBER (B)(4)). THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THE CUSTOMER DECLINED TO PROVIDE THE CORRECT RESULTS FOR ASSESSMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9521643 ↗
• MalfunctionDec 26, 2019High Test Results; High Test Results

  TWO DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON ATELLICA CH 930 ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED USING THE ANOTHER ATELLICA CH 930 ANALYZER (SERIAL NUMBER (B)(4)). THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THE CUSTOMER DECLINED TO PROVIDE THE CORRECT RESULTS FOR ASSESSMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9521640 ↗
• MalfunctionDec 26, 2019High Test Results; High Test Results

  TWO DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON ATELLICA CH 930 ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED USING THE ANOTHER ATELLICA CH 930 ANALYZER (SERIAL NUMBER (B)(4)). THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THE CUSTOMER DECLINED TO PROVIDE THE CORRECT RESULTS FOR ASSESSMENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9521639 ↗
• MalfunctionNov 15, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE CONCENTRATED (CO2_C) RESULT WAS OBTAINED USING AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). REPEAT TESTING WAS PERFORMED USING THE SAME SAMPLE AND SAME ATELLICA CH 930 ANALYZER, RESULTING LOWER AND AS EXPECTED. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9329682 ↗
• MalfunctionNov 15, 2019High Test Results; High Test Results

  DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE CONCENTRATED (CO2_C) RESULTS WERE OBTAINED USING AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). REPEAT TESTING WAS PERFORMED USING THE SAME SAMPLES AND SAME ATELLICA CH 930 ANALYZER, RESULTING LOWER AND AS EXPECTED. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9329681 ↗
• MalfunctionNov 15, 2019High Test Results; High Test Results

  A DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE CONCENTRATED (CO2_C) RESULT WAS OBTAINED USING AN ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). REPEAT TESTING WAS PERFORMED USING THE SAME SAMPLE AND SAME ATELLICA CH 930 ANALYZER, RESULTING LOWER AND AS EXPECTED. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECT RESULT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9329680 ↗
• MalfunctionNov 8, 2019High Test Results; High Test Results

  TWO DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE (CO2_C) RESULT WERE OBTAINED ON ATELLICA CH 930 ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED USING THE SAME ATELLICA CH 930 ANALYZER. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9298718 ↗
• MalfunctionOct 29, 2019High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED USING THE SAME ATELLICA CH 930 ANALYZER. THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9252381 ↗
• MalfunctionOct 29, 2019High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED USING THE SAME ATELLICA CH 930 ANALYZER. THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9252373 ↗
• MalfunctionOct 29, 2019High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED USING THE SAME ATELLICA CH 930 ANALYZER. THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9252367 ↗
• MalfunctionOct 29, 2019High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE (CO2_C) RESULT WAS OBTAINED ON ATELLICA CH 930 ANALYZER. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED USING THE SAME ATELLICA CH 930 ANALYZER. THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9252364 ↗
• MalfunctionOct 29, 2019High Test Results; High Test Results

  TWO DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE (CO2_C) RESULTS WERE OBTAINED ON ATELLICA CH 930 ANALYZER. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED USING THE SAME ATELLICA CH 930 ANALYZER. THE REPEAT RESULTS WERE CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9252359 ↗
• MalfunctionOct 29, 2019High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE (CO2_C) RESULTS WAS OBTAINED ON ATELLICA CH 930 MODULE. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED USING THE SAME ATELLICA CH 930 MODULE. THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9252355 ↗
• MalfunctionOct 28, 2019High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE (CO2_C) RESULTS WAS OBTAINED ON ATELLICA CH 930 MODULE. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED USING THE SAME ATELLICA CH 930 MODULE. THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9244095 ↗
• MalfunctionOct 28, 2019High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE (CO2_C) RESULTS WAS OBTAINED ON ATELLICA CH 930 MODULE. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED USING THE SAME ATELLICA CH 930 MODULE. THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9244087 ↗
• MalfunctionOct 28, 2019High Test Results; High Test Results

  ONE DISCORDANT, FALSELY ELEVATED CARBON DIOXIDE (CO2_C) RESULTS WAS OBTAINED ON ATELLICA CH 930 MODULE. THE INITIAL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED USING THE SAME ATELLICA CH 930 MODULE. THE REPEAT RESULT WAS CONSIDERED CORRECT AND REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED CO2_C RESULT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9244086 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161954. One submission often covers many models, so check the product and lot details in each record.

• Z-1421-2020 · Jan 12, 2020 · Open, Classified
  Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
• Z-1301-2019 · Mar 7, 2019 · Terminated
  Atellica Sample Handler Prime, Material Number 11069001
• Z-0783-2019 · Sep 26, 2018 · Terminated
  Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material Number (SMN): 11069001 - Product Usage: The Atellica Solution is a multi-compo
• Z-0190-2019 · Jun 29, 2018 · Terminated
  Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
• Z-0189-2019 · Jun 29, 2018 · Terminated
  Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
• Z-0191-2019 · Jun 29, 2018 · Terminated
  Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component system for in vitro diagnostic testing of clinical specimens.
• Z-1587-2018 · Feb 26, 2018 · Terminated
  Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.