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Access TSH (3rd IS) C28643Recalls & reported problems

Beckman Coulter, Inc. · The Access TSH (3rd IS) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of human thyroid-stimulating hormone (thyrotropin, TSH, hTSH) levels in human serum and plasma using the Access Immunoassay Systems. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. This assay is capable of providing 3rd generation TSH results. · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

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.

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. Aug 28, 2024Open, Classified

    Certain lots of Access TSH reagent packs may produce erroneously low TSH (thyroid-stimulating hormone) results.

    Z-0094-2025 · Root cause: Under Investigation by firm · FDA record ↗

Other Radioimmunoassay, Thyroid-Stimulating Hormone devices

All Radioimmunoassay, Thyroid-Stimulating Hormone devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page