Alinity 08P5320Recalls & reported problems
Abbott Laboratories · Alinity c Lithium Reagent Kit 190 Tests · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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.
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
- Jun 28, 2019Terminated
Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results
Z-2552-2019 · Root cause: Under Investigation by firm · FDA record ↗
Other Assay, porphyrin, spectrophotometry, lithium devices
- Atellica CH Lithium_2 (LITH_2) 11532401Siemens Healthcare Diagnostics Inc. · Assay, porphyrin, spectrophotometry, lithium2 recalls0 reports
- Atellica CH Li 11097535Siemens Healthcare Diagnostics Inc. · Assay, porphyrin, spectrophotometry, lithium1 recall0 reports
- Lithium 08057974190Roche Diagnostics GmbH · Assay, porphyrin, spectrophotometry, lithium4 reports
- Lithium 4679598190Roche Diagnostics GmbH · Assay, porphyrin, spectrophotometry, lithium3 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
- 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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