Class III — Bion Enterprises Ltd
| Recalling firm | BION ENTERPRISES, LTD. |
|---|---|
| Registered facility | BION ENTERPRISES, LTD. (the firm's only registered facility) |
| Classification | Class III |
| Status | Terminated |
| Reason | Affected products have a labeled expiration date of one year too long. |
| Product | Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits |
| Quantity | 201 units |
| Distribution | Worldwide Distribution - United States (nationwide) in the states of IN, SC and the countries of Canada (Toronto); South Africa (Randburg) and Brazil (Rio de Janeiro) |
| Initiated | 2013-01-23 |
| Classified | 2013-06-05 |
| Terminated | 2015-05-05 |
| Recall number | Z-1478-2013 |
| 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 III recall — Bion Enterprises Ltd (Z-1478-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/64164/
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