CLASS III Device recall · Reported 12 Jun 2013 · FDA Enforcement Report
containing of IgG Conjugate recalled by Bion Enterprises
Bion Enterprises is recalling containing of IgG Conjugate, distributed nationwide in the US. The recall was initiated on 23 Jan 2013 and the FDA has classified it as Class III.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1477-2013
- FDA event ID
- 64164
- Recalling firm
- Bion Enterprises, Des Plaines, IL
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 23 Jan 2013
- FDA classified
- 5 Jun 2013
- Reported
- 12 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Foreign Material
- Device type
- Test Kits & Diagnostics
Timeline
| 23 Jan 2013 | Recall initiated by company | |
| 5 Jun 2013 | Classified by FDA | +133 days |
| 12 Jun 2013 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Affected products have a labeled expiration date of one year too long.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits
Where it was distributed
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)
Questions about this recall
Is containing of IgG Conjugate recalled?
Yes. Bion Enterprises recalled containing of IgG Conjugate on 23 Jan 2013. The recall is Class III and its status is Terminated. Recall number Z-1477-2013.
Why was it recalled?
Affected products have a labeled expiration date of one year too long.
Which lots are affected?
Product Code: CCG-9912; Lot: CCG-0280
Where was it sold?
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)
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bion Enterprises
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | containing of IgM Conjugate recalled by Bion Enterprises | Bion Enterprises | Foreign Material | Nationwide |
| Device | CLASS III | containing of IgG FITC Conjugate recalled by Bion Enterprises | Bion Enterprises | Foreign Material | Nationwide |
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