FDAFDA · Food and drugs·Recall number 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 assay kits
Published June 12, 2013 · Recall initiated: January 23, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Affected products have a labeled expiration date of one year too long.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Bion Enterprises Ltd
- Distributor
- 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)
- Lot
- Product Code: CCM-9914; Lot: CCM-0281
- Risk classification
- Class III
- Area (FDA)
- device
- Country
- United States
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