AU OSR6637Recalls & reported problems

Summary

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

2 FDA recall records name this device's identifier, 2 still open.

2 other recalls cover devices cleared under the same FDA submission (K131546); 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. Oct 14, 2025Open, Classified

   Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample.

   Z-0997-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

2. Apr 5, 2023Open, Classified

   There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.

   Z-1608-2023 · Root cause: Under Investigation by firm · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131546. One submission often covers many models, so check the product and lot details in each record.

• Z-1606-2023 · Apr 5, 2023 · Open, Classified
  Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL
• Z-1607-2023 · Apr 5, 2023 · Open, Classified
  Beckman Coulter Bicarbonate, REF: OSR6237, 4x50 mL