Recall Z-1478-2013— Bion Enterprises Ltd

Name: FDA recall Z-1478-2013
Creator: U.S. Food and Drug Administration
Published: 2013-01-23

Class III · Terminated

Class III FDA medical device recall by Bion Enterprises Ltd, initiated 2013-01-23, terminated 2015-05-05. It names one FDA 510(k) clearance: K880679. 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. Reason: Affected products have a labeled expiration date of one year too long..

Recalling firm: Bion Enterprises Ltd
Classification: Class III
Status: Terminated
Initiated: 2013-01-23
Terminated: 2015-05-05
Firm location: Des Plaines, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K880679 — BION CMV-G TEST SYSTEMBion Ent., Ltd.·cleared 1988-06-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.