Recall Z-1478-2013
Bion Enterprises Ltd · initiated January 23, 2013
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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
Codes / lots: Product Code: CCM-9914; Lot: CCM-0281
Reason for recall
Affected products have a labeled expiration date of one year too long.
FDA-determined cause: Error in labeling
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.
Details
- Recall number
- Z-1478-2013
- Initiated
- January 23, 2013
- Posted by FDA
- June 5, 2013
- Terminated
- May 5, 2015
- Product code
- GQH – Antigen, Cf (Including Cf Control), Cytomegalovirus
- 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)
- Recalling firm
- Bion Enterprises Ltd, Des Plaines, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1477-2013 Class III | Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a…Affected products have a labeled expiration date of one year too long. | 01/23/2013Terminated |
| Z-1479-2013 Class III | Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used…Affected products have a labeled expiration date of one year too long. | 01/23/2013Terminated |