Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent KitRecalls & reported problems across all models

We found 2 models of Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit by Axis-Shield Diagnostics Limited 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

Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit 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.

1. Sep 16, 2019Class IIOpen, Classified

   There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

   Z-0744-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Sep 16, 2019Class IIOpen, Classified

   There is a potential performance issue as detected by an under-recovery of sample results during routine testing.

   Z-0743-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit FHRWR100

  Calibrator, Secondary
  1 recall0 reports
• Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit FHRWR1000
  1 recall0 reports