Z-0775-2014Class II

Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision...

Name: Z-0775-2014 Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision...
Creator: Lab Vision Corporation
Published: 2013-12-06
License: https://open.fda.gov/license/

Lab Vision Corp. / initiated 2013-12-06 / Terminated

FDA source

Lab Vision Corporation began a recall of Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific... on 2013-12-06. FDA classified it as Class II and gives the reason as "Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0775-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-06
Posted: 2014-01-16
Terminated: 2014-02-25
Recalling firm: Lab Vision Corp.
Product: Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.
Product code: MVU Reagents, Specific, Analyte
Reason for recall: Reports that the product is not performing as expected. In house testing showed no staining on breast cancer tissues.
FDA root cause: Under Investigation by firm
Action: Lab Vision Corporation part of Thermo Fisher Scientific sent an Urgent Medical Device Recall letter dated December 6, 2013, to all affected customers. Revised letters will be sent on January 8, 2014. Changes include that the reagent is an Analyte Specific Reagent (ASR) and not an in vitro diagnostic device in the US. They also clarify that a false positive was reported by a customer and a false negative was confirmed during in house testing. Letters also correct the expiry date from 12/2013 to 03/2015. Data sheet was also updated to eliminate information stating that the presence of ER in breast tumors indicates an increased likelihood of response to estrogen therapy and also that the positive control must be determined by the investigator. If you have any questions, please contact Technical Service at 1-800-522-7270, option 2, option 7.
Quantity in commerce: 5
Distribution: Worldwide Distribution: US (nationwide) including the states of TX and MA and internationally to: Turkey.
Product codes and lots: PN/ MS-354-P0, LN 354P1206K; Expiration 03/2015.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0775-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0775-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-22	2014-01-16

Product code MVU

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)