Estrone RIA DSL8700Recalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

3 FDA recall records name this device's identifier, 3 still open.

1 other recall cover devices cleared under the same FDA submission (K935013); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 15, 2025Open, Classified

   The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur.

   Z-1369-2026 · Root cause: Equipment maintenance · FDA record ↗

2. Jun 12, 2025Open, Classified

   A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing falsely increased assay results for the impacted Estrone RIA kits.

   Z-2152-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

3. Jun 12, 2025Open, Classified

   Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability or rarely give falsely low patient results which might cause Permanent injury of Remote probability. Only in some (very rare) cases may the issue occur.

   Z-2336-2025 · Root cause: Nonconforming Material/Component · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K935013. One submission often covers many models, so check the product and lot details in each record.

• Z-1685-2011 · Apr 22, 2010 · Terminated
  Estrone Radioimmunoassay (RIA) Kit, DSL-8700. Intended for in vitro diagnostic use.