ACL ELITE 00000880311Recalls & reported problems

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 (K060162); 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 16, 2026.

Recalls naming this device

1. 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-1304-2023 · Root cause: Device Design · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K060162. One submission often covers many models, so check the product and lot details in each record.

• Z-0807-2011 · Nov 11, 2010 · Terminated
  ACL ELITE PRO Coagulation Analyzer, PN 00001000311 Coagulation testing.
• Z-0804-2011 · Nov 11, 2010 · Terminated
  ACL 9000 Coagulation Analyzer, PN 00000990011 Coagulation testing.
• Z-0803-2011 · Nov 11, 2010 · Terminated
  ACL 8000 Coagulation Analyzer, PN 00000880011 Coagulation testing.
• Z-0805-2011 · Nov 11, 2010 · Terminated
  ACL 10000 Coagulation Analyzer, PN 0000100011 Coagulation testing.
• Z-0806-2011 · Nov 11, 2010 · Terminated
  ACL ELITE Coagulation Analyzer, PN 00000880311 Coagulation testing.