FDA Device recall Z-1478-2013
Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assa…
- FDA Device
- Class III
- terminated
- Published 2013-06-12
On 2013-06-12 the FDA classified a Class III recall of Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assa… by Bion Enterprises, citing affected products have a labeled expiration date of one year too long.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1478-2013 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2013-01-23 |
| Published | 2013-06-12 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Bion Enterprises |
| Distribution | US |
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
Reason
Affected products have a labeled expiration date of one year too long.
Identifiers
| code_info | Product Code: CCM-9914; Lot: CCM-0281 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1478-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.