Z-1478-2013Class III

Plastic bottle containing 10.5 mL of IgM Conjugate

Name: Z-1478-2013 Plastic bottle containing 10.5 mL of IgM Conjugate
Creator: Bion Enterprises Ltd
Published: 2013-01-23
License: https://open.fda.gov/license/

Bion Enterprises Ltd / initiated 2013-01-23 / Terminated / root cause: labeling and UDI

FDA source

Bion Enterprises Ltd began a recall of Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage: Product is a used as a counterstain for various indirect fluorescent assay kits on 2013-01-23. FDA classified it as Class III and gives the reason as "Affected products have a labeled expiration date of one year too long". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1478-2013
Classification: Class III
Status: Terminated
Initiated: 2013-01-23
Posted: 2013-06-05
Terminated: 2015-05-05
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
Product code: GQH Antigen, Cf (Including Cf Control), Cytomegalovirus
Reason for recall: Affected products have a labeled expiration date of one year too long.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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)
Product codes and lots: Product Code: CCM-9914; Lot: CCM-0281

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1478-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1477-2013	Class III	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-05
Z-1478-2013	Class III	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-05
Z-1479-2013	Class III	Terminated	Voluntary: Firm initiated	2013-06-12	2013-06-05

Product code GQH

K880679Class IIBion Cmv-G Test SystemBion Ent., Ltd. / cleared 1988-06-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)