Z-3180-2011

Leica Bond Aspirating Probe Cleaning System; an in vitro diagnostic immunohistochemistry probe cleaning...

Name: Z-3180-2011 Leica Bond Aspirating Probe Cleaning System; an in vitro diagnostic immunohistochemistry probe cleaning...
Creator: Leica Microsystems, Inc.
Published: 2011-07-26
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2011-07-26 / Terminated / root cause: manufacturing process

FDA source

Leica Microsystems, Inc. began a recall of Leica Bond Aspirating Probe Cleaning System; an in vitro diagnostic immunohistochemistry probe cleaning reagent kit; Catalog No. CS9100; Leica Biosystems... on 2011-07-26. The reason FDA records is "There was an issue with the controlled temperature storage unit where the products were stored prior to shipment to the customers". 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-3180-2011
Status: Terminated
Initiated: 2011-07-26
Posted: 2011-09-09
Terminated: 2011-09-09
Recalling firm: Leica Microsystems, Inc.
Product: Leica Bond Aspirating Probe Cleaning System; an in vitro diagnostic immunohistochemistry probe cleaning reagent kit; Catalog No. CS9100; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. The Bond Aspirating Probe Cleaning System is intended for automated cleaning of aspirating probes on Bond-max and Bond-x instruments, using the aspirating probe cleaning protocol installed in Bond systems. Product Quantity Distributed (Int) 1 kit
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: There was an issue with the controlled temperature storage unit where the products were stored prior to shipment to the customers.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Leica Microsystems, Inc. notified all affected customers by telephone on July 26, 2011. The product, problem, and actions to be taken by the customers were discussed. Customers were instructed to discontinue use of the product and to return the product. All affected product has been returned to the firm.
Quantity in commerce: 1 kit
Distribution: Nationwide Distribution-in the states of Indiana and Kentucky.
Product codes and lots: Catalog number CS9100, lot number 13808

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)