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Recall Observatory FDA recall evidence

Device 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

Z-1477-2013

January 23, 2013

Class III

Product summary

Firm
Bion Enterprises Ltd
Event
Event 64164
Status
Terminated
Classification
Class III
Quantity
207 units
Official record key
device-enforcement:Z-1477-2013

Official wording

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

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)

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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