Alinity 08P3620Recalls & reported problems
Abbott Ireland · Alinity i Progesterone Reagent Kit 200 Tests · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00380740121877), received between Nov 21, 2018 and Nov 21, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Damaged Prior to Use” (1 report).
1 FDA recall record name this device's identifier.
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.
Recalls naming this device
- Nov 21, 2018Terminated
Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
Z-0668-2019 · Root cause: Nonconforming Material/Component · FDA record ↗
Most reported problems
Device problems
- Device Damaged Prior to Use1
- Unable to Obtain Readings1
Patient problems
- No Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 21, 2018Unable to Obtain Readings; Device Damaged Prior to Use; Unable to Obtain Readings; Device Damaged Prior to Use
ABBOTT LABORATORIES HAS BECOME AWARE OF A MANUFACTURING ISSUE THAT CAN RESULT IN DAMAGE TO A BOTTLE NECK IN SOME REAGENT CARTRIDGES. IF A BOTTLE NECK IS DAMAGED, IT MAY CAUSE A FAILURE DURING THE REAGENT LOADING PROCESS ON THE ALINITY I INSTRUMENT. WHEN THE FAILURE OCCURS, ERROR CODES WILL BE GENERATED WHICH MAY LEAD TO THE POTENTIAL OF DELAYED PATIENT RESULTS. NO PATIENT INJURY HAS BEEN REPORTED DUE TO THIS ISSUE.
Patient problems: No Patient Involvement
MAUDE report 8097098 ↗
Other RADIOIMMUNOASSAY, PROGESTERONE devices
- IMMULITE® 2000 Systems PRG Progesterone 10381181Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PROGESTERONE1 recall4 reports
- IMMULITE® 2000 Systems PRG Progesterone 10381170Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PROGESTERONE1 recall3 reports
- VIDAS® Progesterone 30409-01Biomerieux SA · RADIOIMMUNOASSAY, PROGESTERONE1 recall1 report
- ARCHITECT 7K77-25Abbott Ireland · RADIOIMMUNOASSAY, PROGESTERONE1 recall1 report
- IMMULITE 2000 Progesterone Kit Domestic 600T 10901874Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PROGESTERONE1 recall0 reports
- IMMULITE®/IMMULITE® 1000 Systems PRG Progesterone 10381128Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PROGESTERONE1 recall0 reports
- IMMULITE 2000 Progesterone Kit Domestic 200T 10901873Siemens Healthcare Diagnostics Products Ltd · RADIOIMMUNOASSAY, PROGESTERONE1 recall0 reports
- Atellica IM PRGE 10995659Siemens Healthcare Diagnostics Inc. · RADIOIMMUNOASSAY, PROGESTERONE16 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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