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Terminated

Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit containing reagent vials, Bio-Genex, San Ramon, CA.

FDA Recall Z-0217-2007 · Posted 2006-12-08

Recalling FirmBiogenex Laboratories
Recall StatusTerminated
Product CodeNJT
Date Initiated2006-10-03
Date Terminated2007-12-04
Product Quantity158 units

Reason for Recall

Mislabeling: The product's "contents section " labeling (outer box) is mislabeled incorrectly printed as '1 x 100 mL Alk Phos Label' which should read '1 x 100 mL HRP Label'. A second, smaller label, incorrectly reads "RTU MultiLink HPR/AEC" which should be labeled as "RTU MultiLink HPR". The reagent vials in the box are correctly labeled.

Firm Action

The firms provided written notificaiton letter on approximately 10/03/06, which includes a ''reply back form'' which the firm has requested to be sent back to them. The firm has asked distributors to inform their accounts of the correction, in the event that the product has been shipped out to customers.

Root Cause

Other

Distribution Pattern

Worldwide-USA (including VA Medical Center) and Greece, Jordan, France, India, Taiwan, United Kingdom, Turkey, and Italy

Official Source

View FDA Recall →

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

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