Class II — Beckman Coulter Inc.
| Recalling firm | BECKMAN COULTER, INC. |
|---|---|
| Registered facility | View this company's 22 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The Access immunoassays are susceptible to biotin interference. |
| Product | Access Thyroglobulin, A34085G, Catalog No. 33860 |
| Quantity | 83,504 units total (23,285 units in US) |
| Distribution | Algeria, Angola, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Ir… |
| Initiated | 2017-05-09 |
| Classified | 2017-06-28 |
| Terminated | 2018-03-30 |
| Recall number | Z-2636-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Beckman Coulter Inc. (Z-2636-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77245/
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