FDA Medical Device Recalls (openFDA)
Bion Enterprises Ltd: Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
- Recall number
- Z-1478-2013
- Recalling firm
- Bion Enterprises Ltd
- 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
- Status
- Terminated
- Initiated
- 2013-01-23
- Posted
- 2013-06-05
- Terminated
- 2015-05-05
- Reason
- Affected products have a labeled expiration date of one year too long.
- Root cause
- Error in labeling
- Action
- 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.
- 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)
- Lot, serial or model codes
- Product Code: CCM-9914; Lot: CCM-0281
- 510(k) numbers
- ["K880679"]
- PMA numbers
- not on file
- Product code
- GQH
- Firm FEI
- 1419968
- Firm city
- Des Plaines
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28