Z-0217-2007

Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit...

Name: Z-0217-2007 Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit...
Creator: Biogenex Laboratories
Published: 2006-10-03
License: https://open.fda.gov/license/

Biogenex Laboratories, Inc. / initiated 2006-10-03 / Terminated / root cause: labeling and UDI

FDA source

Biogenex Laboratories began a recall of 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 on 2006-10-03. The reason FDA records is "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...". 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-0217-2007
Status: Terminated
Initiated: 2006-10-03
Posted: 2006-12-08
Terminated: 2007-12-04
Recalling firm: Biogenex Laboratories, Inc.
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.
Product code: NJT Immunohistochemistry Reagents And Kits
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.
Root cause tag: labeling and UDI
FDA root cause: Other
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.
Quantity in commerce: 158 units
Distribution: Worldwide-USA (including VA Medical Center) and Greece, Jordan, France, India, Taiwan, United Kingdom, Turkey, and Italy
Product codes and lots: Catalog Number QP300-XAK, Lot numbers QP3000905B, QP3000905C, QP3001205B, QP3001005, QP3001205, QP3000206, QP3001205C, QP3000506, QP3000506B, QP3000506C, QP3000606, QP3000706.

Product code NJT

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)