HemosIL Heparin Calibrators 00020300600Recalls & reported problems
Instrumentation Laboratory Company · HemosIL Heparin Calibrators · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
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.
5 other recalls cover devices cleared under the same FDA submission (K090209); 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 18, 2026.
Recalls naming this device
- Dec 18, 2024Class IIOpen, Classified
Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range.
Z-1020-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K090209. One submission often covers many models, so check the product and lot details in each record.
- Z-1307-2023 · Feb 3, 2023 · Open, ClassifiedACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311R
- Z-1306-2023 · Feb 3, 2023 · Open, ClassifiedACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R
- Z-1304-2023 · Feb 3, 2023 · Open, ClassifiedACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311
- Z-1305-2023 · Feb 3, 2023 · Open, ClassifiedACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311
- Z-0149-2022 · Aug 25, 2021 · Open, ClassifiedHemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human cit
Other CALIBRATOR, PRIMARY devices
- ARCHITECT 2K43-25Abbott Ireland Diagnostics · CALIBRATOR, PRIMARY1 recall23 reports
- ARCHITECT 2K43-01Abbott Ireland Diagnostics · CALIBRATOR, PRIMARY1 recall10 reports
- VITROS 1112820Ortho Clinical Diagnostics · CALIBRATOR, PRIMARY1 recall0 reports
- Access Total T4 Calibrators 33805Beckman Coulter, Inc. · Calibrator, Primary1 recall0 reports
- ADVIA Centaur® Systems, ACS:180® Systems HCY Calibrator 10310376Siemens Healthcare Diagnostics Inc. · CALIBRATOR, PRIMARY1 recall0 reports
- Atellica IM HCY Calibrator 10995498Siemens Healthcare Diagnostics Inc. · Calibrator, primary1 recall0 reports
- VITROS 6802344Ortho-Clinical Diagnostics, Inc. · CALIBRATOR, PRIMARY1 recall0 reports
- ARCHITECT 2K42-25Abbott Ireland Diagnostics · CALIBRATOR, PRIMARY1 report
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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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