SP CONTROL 3 PS2684Recalls & 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 (K972608); 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. Nov 22, 2022Open, Classified

   Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range

   Z-0905-2023 · Root cause: Under Investigation by firm · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K972608. One submission often covers many models, so check the product and lot details in each record.

• Z-0904-2023 · Nov 22, 2022 · Open, Classified
  Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683
• Z-0903-2023 · Nov 22, 2022 · Open, Classified
  Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1
• Z-2278-2018 · May 22, 2018 · Terminated
  Randox Liquid Assayed Specific Protein Control - Level 1 (SP Control 1), Cat. no. PS2682
• Z-2279-2018 · May 22, 2018 · Terminated
  Randox Liquid Assayed Specific Protein Control - Level 2 (SP Control 2), Cat. no. PS2683
• Z-2280-2018 · May 22, 2018 · Terminated
  Randox Liquid Assayed Specific Protein Control - Level 3 (SP Control 3), Cat. no. PS2684