Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indire
FDA device recall Z-1478-2013 · posted 2013-06-05 · Terminated
Recall details
- Recalling firm
- Bion Enterprises Ltd
- Reason for recall
- Affected products have a labeled expiration date of one year too long.
- Action taken
- 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.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- GQH
- Quantity affected
- 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)
- Date initiated
- 2013-01-23
- Date posted
- 2013-06-05
- Date terminated
- 2015-05-05
- Location
- Des Plaines, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BION CMV-G TEST SYSTEM (K880679) | Bion Ent., Ltd. | 1988-06-03 |