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Terminated

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

FDA Recall Z-1477-2013 · Posted 2013-06-05

Recalling FirmBion Enterprises Ltd
Recall StatusTerminated
Product CodeGQO
Date Initiated2013-01-23
Date Terminated2015-05-05
Product Quantity207 units

Reason for Recall

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

Firm 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.

Root Cause

Error in labeling

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)

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K881261BION HSV1-G OR HSV2-G TEST SYSTEMBion Ent., Ltd. · 1988-06-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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