Z-1086-2012

UltraVision Large Volume Detection System; Anti-Polyvalent, Alk-Phos (Ready to Use) Manufactured by: Lab...

Name: Z-1086-2012 UltraVision Large Volume Detection System; Anti-Polyvalent, Alk-Phos (Ready to Use) Manufactured by: Lab...
Creator: Lab Vision Corporation
Published: 2012-01-11
License: https://open.fda.gov/license/

Lab Vision Corp. / initiated 2012-01-11 / Terminated / root cause: manufacturing process

FDA source

Lab Vision Corporation began a recall of UltraVision Large Volume Detection System; Anti-Polyvalent, Alk-Phos (Ready to Use) Manufactured by: Lab Vision Corporation 46360 Fremont Blvd, Fremont, CA... on 2012-01-11. The reason FDA records is "Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1086-2012
Status: Terminated
Initiated: 2012-01-11
Posted: 2012-02-22
Terminated: 2012-07-20
Recalling firm: Lab Vision Corp.
Product: UltraVision Large Volume Detection System; Anti-Polyvalent, Alk-Phos (Ready to Use) Manufactured by: Lab Vision Corporation 46360 Fremont Blvd, Fremont, CA 94538 Product Usage: These products detect specific antibodies bound to an antigen in tissue sections. The specific antibody is located by a biotin-conjugated secondary antibody. This step is followed by the addition of streptavidin-enzyme conjugate that binds to the biotin preset on the secondary antibody. The specific antibody, secondary antibody, and streptavidin-enzyme complex is then visualized with an appropriate substrate/chromogen.
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: Firm was notified by vendor that a component in kits was not meeting internal specifications. Declination in product performance confirmed by Thermo Fisher.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Lab Vision Corporation of Thermo Fisher Scientific sent a Product Recall Notification letters dated January 11, 2012 to all affected customers. The letter identified the affected products, reason for recall and necessary actions to be taken. Customers were instructed to examine inventory, discontinue use, destroy any remaining inventory, follow normal procedure to order an alternate lot of the affected products, retain a copy of this letter for their laboratory records, if the affected products were further distributed provide a copy of this letter to them and complete the attached Customer Recall Response Form and return within 5 days. For questions regarding this information, U.S. customers should call Technical Support at 510-771-1595. Customers outside the U.S. should contact their local area Customer Service.
Quantity in commerce: 31 kits in total
Distribution: Worldwide Distribution - USA (nationwide) FL, IL, MA, TX and countries of Denmark, Turkey, Italy, Poland, Canada, Japan, Germany, Egypt and Greece.
Product codes and lots: Catalog number: TP-060-AL; Lot Number: PAL110310, Exp. 12/2012. Catalog number TP-125-AL; Lot Number: PAL110325, Exp 1/2013; Lot Number: PAL111019, Exp. 10/2012. .

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)