Plastic bottle containing 3 — Class III medical device recall Z-1479-2013
Terminated recall by Bion Enterprises Ltd, reported 2013-06-12, distributed nationwide. Affected products have a labeled expiration date of one year too long.
| Recall number | Z-1479-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bion Enterprises Ltd, Des Plaines, IL, United States |
| Recall initiated | 2013-01-23 |
| Classified | 2013-06-05 |
| Reported by FDA | 2013-06-12 |
| Terminated | 2015-05-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | BR, CA, ZA |
| Quantity | 504 units |
| Reason classes | labeling |
| Lot numbers | CCG-0281 |
Product
Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
Reason for recall
Affected products have a labeled expiration date of one year too long.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1479-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.