Bion Enterprises Ltd: Medical Device Recall in 2013 - (Recall #: Z-1477-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits

Product Classification:

Class III

Date Initiated: January 23, 2013

Date Posted: June 12, 2013

Recall Number: Z-1477-2013

Event ID: 64164

Reason for Recall:

Affected products have a labeled expiration date of one year too long.

Status: Terminated

Product Quantity: 207 units

Code Information:

Product Code: CCG-9912; Lot: CCG-0280

Distribution Pattern:

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)

Voluntary or Mandated:

Voluntary: Firm initiated