Synchron 467868Recalls & reported problems
Beckman Coulter, Inc. · SYNCHRON Systems Phosphorus Reagent · Class 1
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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
- Sep 3, 2025Open, Classified
Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.
Z-0071-2026 · Root cause: Unknown/Undetermined by firm · FDA record ↗
Other Phosphomolybdate (Colorimetric), Inorganic Phosphorus devices
- VITROS 1513209Ortho-Clinical Diagnostics, Inc. · Phosphomolybdate (colorimetric), inorganic phosphorus1 recall0 reports
- Phosphate (Inorganic) ver.2 03183793122Roche Diagnostics GmbH · Phosphomolybdate (colorimetric), inorganic phosphorus11 reports
- Phosphate (Inorganic) ver.2 5171377190Roche Diagnostics GmbH · Phosphomolybdate (colorimetric), inorganic phosphorus5 reports
- Phosphate (Inorganic) ver.2 08058610190Roche Diagnostics GmbH · Phosphomolybdate (colorimetric), inorganic phosphorus4 reports
- ARCHITECT 7D71-23Abbott GmbH · Phosphomolybdate (colorimetric), inorganic phosphorus2 reports
- Dimension Vista® Flex® reagent cartridge PHOS 10445144Siemens Healthcare Diagnostics Inc. · Phosphomolybdate (colorimetric), inorganic phosphorus1 report
- Alinity 08P4030Abbott GmbH · Phosphomolybdate (colorimetric), inorganic phosphorus1 report
- Atellica CH IP 11097611Siemens Healthcare Diagnostics Inc. · Phosphomolybdate (colorimetric), inorganic phosphorus1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.