ACL ELITE PRORecalls & reported problems across all models
Instrumentation Laboratory Company · 2 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
2 open recalls name at least one ACL ELITE PRO model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 2
We found 2 models of ACL ELITE PRO by Instrumentation Laboratory Company in the FDA's device registry (GUDID). None of them is named in an adverse event report in our data.
2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
ACL ELITE PRO recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Feb 3, 2023Open, Classified
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
Z-1307-2023 · Root cause: Device Design · Recall details · FDA record ↗
- Feb 3, 2023Open, Classified
Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
Z-1305-2023 · Root cause: Device Design · Recall details · FDA record ↗
ACL ELITE PRO models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- ACL ELITE PRO 00001000311SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall0 reports
- ACL ELITE PRO 00001000311RSYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES1 recall0 reports
Other Instrumentation Laboratory Company products
All Instrumentation Laboratory Company devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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