Atellica CH Pcp 11097509Recalls & reported problems
Siemens Healthcare Diagnostics Inc. · Phencyclidine (Pcp) - Atellica CH - RGT - 1520T · Class U
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00630414596044), received between Oct 29, 2019 and Oct 29, 2019 — classified as 1 malfunction.
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.
Most reported problems
Device problems
- No Apparent Adverse Event1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 29, 2019No Apparent Adverse Event; No Apparent Adverse Event
ON (B)(6) 2019, SIEMENS WAS INFORMED OF A REPORT (MW5090047) THAT WAS RECEIVED THROUGH FDA'S MEDWATCH PROGRAM. IN THIS REPORT, THE CUSTOMER INDICATED THAT WHEN ATELLICA CH PHENCYCLIDINE (PCP) REAGENT BOTTLES ARE PLACED ONTO THE ATELLICA ANALYZER, THE REAGENT LABELS LOSE ADHERENCE TO THE BOTTLES AND COVER THE BARCODES. THE CUSTOMER'S WORK AROUND FOR THIS ISSUE WAS PLACING TAPE ON THE REAGENT BOTTLES; THE CUSTOMER STATED THAT IF THE REAGENT LABELS WERE INCORRECTLY TAPED ONTO THE BOTTLES, THE TAPE CAUSED AN INSTRUMENT MALFUNCTION. THE CUSTOMER ALLEGED THAT PATIENT CARE WAS DELAYED DUE TO AN INSTRUMENT MALFUNCTION CAUSED BY A WORK AROUND IMPLEMENTED BY THE CUSTOMER. THE CUSTOMER DID NOT PROVIDE ANY FURTHER INFORMATION REGARDING THE DELAY IN PATIENT CARE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THIS ISSUE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9251053 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page