Recall Z-1479-2013 ยท LJY Enzyme Linked Immunoabsorbent Assay, Mumps Virus
Bion Enterprises Ltd
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
| Date | Jun 5, 2013 (initiated Jan 23, 2013) |
| Status | Terminated |
| Reason | Affected products have a labeled expiration date of one year too long. |
| Root cause | Error in labeling |
| Action | MBL Bion sent an Urgent Product Recall letter dated January 28, 2013 to all affected customers via email. The letter identified the affected product, problem and actions to be taken. Customers were requested to destroy the affected product and to notify Bion of the number of units consumed and destroyed. For questions call 847-544-5044. |
| Quantity | 504 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) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K926066 | BION MUMPS-G ANTIBODY TEST SYSTEM Bion Ent., Ltd., Jun 15, 1993 |