Biogenex Laboratories 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Biogenex Laboratories
Lot Codes / Batch Numbers
Catalog Number QP300-XAK, Lot numbers QP3000905B, QP3000905C, QP3001205B, QP3001005, QP3001205, QP3000206, QP3001205C, QP3000506, QP3000506B, QP3000506C, QP3000606, QP3000706.
Products Sold
Catalog Number QP300-XAK, Lot numbers QP3000905B, QP3000905C, QP3001205B, QP3001005, QP3001205, QP3000206, QP3001205C, QP3000506, QP3000506B, QP3000506C, QP3000606, QP3000706.
Biogenex Laboratories is recalling Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300- due to Mislabeling: The product's "contents section " labeling (outer box) is mislabeled incorrectly printed as '1 x 100 mL Alk Phos Label' which should r. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
VA
Page updated: Jan 10, 2026