Bion Enterprises IgG Conjugate Recalled for Incorrect Expiration Date Labeling
Bion Enterprises Ltd is recalling 207 units of IgG Conjugate because the labeled expiration date is one year too long.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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 is defined as unlikely to cause adverse health consequences. The issue is a minor labeling error regarding the expiration date.
Plain-English summary
Bion Enterprises Ltd is recalling 207 units of IgG Conjugate, a plastic bottle containing 10.5 mL of product used as a counterstain for indirect fluorescent assay kits. The recall is due to a labeling error where the expiration date is listed as one year longer than it should be.
The affected product is identified by Product Code CCG-9912 and Lot CCG-0280. The units were distributed nationwide in the United States (specifically in Indiana and South Carolina) and internationally to Canada (Toronto), South Africa (Randburg), and Brazil (Rio de Janeiro).
Consumers and laboratories should stop using the affected product and contact Bion Enterprises Ltd for further instructions or a refund.
The recalled product
- Product
- Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
- Manufacturer
- Bion Enterprises Ltd
- Hazard
- Affected units
- 207
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: CCG-9912
- Lot: CCG-0280
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 IgM Conjugate Recalled for Incorrect Expiration Date Labeling
FDA (Devices) · 2013-06-12
- LowBion Enterprises IgG FITC Conjugate Recalled for Incorrect Expiration Date
FDA (Devices) · 2013-06-12
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