Bion Enterprises IgM Conjugate Recalled for Incorrect Expiration Date Labeling
Bion Enterprises is recalling 201 units of IgM Conjugate because the labeled expiration date is one year too long.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is a documentation/labeling error.
Plain-English summary
Bion Enterprises Ltd is recalling 201 units of a plastic bottle containing 10.5 mL of IgM Conjugate. The product is used as a counterstain for various indirect fluorescent assay kits. The recall is due to a labeling error where the expiration date is listed as one year too long.
The affected product has the code CCM-9914 and lot number CCM-0281. The recall is classified as Class III by the FDA, indicating that use of the product is not likely to cause adverse health consequences.
The product was distributed worldwide, including in the United States (Indiana, South Carolina), Canada (Toronto), South Africa (Randburg), and Brazil (Rio de Janeiro). Users should stop using the product and contact the manufacturer for instructions.
The recalled product
- 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
- Manufacturer
- Bion Enterprises Ltd
- Hazard
- Affected units
- 201
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Product Code: CCM-9914
- Lot: CCM-0281
Distribution
Part of a larger recall action
This product is one of 3 recalled by Bion Enterprises Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Bion Enterprises Ltd
See all →- LowBion Enterprises IgG FITC Conjugate Recalled for Incorrect Expiration Date
FDA (Devices) · 2013-06-12
- LowBion Enterprises IgG Conjugate Recalled for Incorrect Expiration Date Labeling
FDA (Devices) · 2013-06-12
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