ACL TOP 750 00000280015Recalls & reported problems
Instrumentation Laboratory Company · ACL TOP 750 · 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.
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
- Jul 13, 2023Class IIOpen, Classified
Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result
Z-2578-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other INSTRUMENT, COAGULATION, AUTOMATED devices
- BCS® XP System 10459330Siemens Healthcare Diagnostics Products GmbH · INSTRUMENT, COAGULATION, AUTOMATED1 recall63 reports
- ACL TOP 550 CTS 00000280045Instrumentation Laboratory Company · INSTRUMENT, COAGULATION, AUTOMATED2 recalls3 reports
- ACL TOP 350 CTS 00000280065Instrumentation Laboratory Company · INSTRUMENT, COAGULATION, AUTOMATED2 recalls1 report
- ACL TOP 500 CTS 00000280040Instrumentation Laboratory Company · INSTRUMENT, COAGULATION, AUTOMATED1 recall8 reports
- ACL TOP 750 LAS 00000280035Instrumentation Laboratory Company · INSTRUMENT, COAGULATION, AUTOMATED1 recall4 reports
- ACL TOP 750 CTS 00000280055Instrumentation Laboratory Company · INSTRUMENT, COAGULATION, AUTOMATED1 recall3 reports
- ACL TOP 300 CTS 00000280060Instrumentation Laboratory Company · INSTRUMENT, COAGULATION, AUTOMATED1 recall1 report
- ACL TOP 500 CTS 00000280040RInstrumentation Laboratory Company · INSTRUMENT, COAGULATION, AUTOMATED1 recall0 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 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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