Device recall: Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various…
Class III FDA enforcement event 64164. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
Affected products have a labeled expiration date of one year too long.
Class III, in the words of FDA
a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences
Bion Enterprises Ltd started this device recall on 23 Jan 2013. The firm address in the FDA record is in Des Plaines, IL. FDA put the recall in Class III. FDA event 64164 has 3 product records. The first FDA enforcement report date is 12 Jun 2013. The record gives the status Terminated, with the termination date 5 May 2015.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
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)
Recalling firm
Bion Enterprises Ltd, Des Plaines, IL.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
3 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1477-2013 | Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits | 207 units | Class III | Terminated | 12 Jun 2013 |
| Z-1478-2013 | Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits | 201 units | Class III | Terminated | 12 Jun 2013 |
| Z-1479-2013 | Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits | 504 units | Class III | Terminated | 12 Jun 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class III: The lowest of the three FDA recall classes.
The event in context
- Device events that started in 2013
- 1,236
- Share of these events in Class III
- 5%
- Product records in this event
- 3
- Events of the firm on the register
- 1
Official channels
- FDA enforcement report Z-1477-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 64164. https://recallregister.com/fda/iii/64164/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this 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)
- What quantity of product is in FDA event 64164?
- The event has 3 product records. The first record gives this quantity:
207 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2013 have the same class?
- 5% of the 1,236 device events that started in 2013 are in Class III.