Z-0341-2016Class II

Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic...

Name: Z-0341-2016 Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic...
Creator: Leica Microsystems, Inc.
Published: 2015-09-03
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2015-09-03 / Terminated / root cause: manufacturing process

FDA source

Leica Microsystems, Inc. began a recall of Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended... on 2015-09-03. FDA classified it as Class II and gives the reason as "These Lot numbers are not stable up to the expiry date on the product labeling". 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-0341-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-03
Posted: 2015-11-25
Terminated: 2017-11-30
Recalling firm: Leica Microsystems, Inc.
Product: Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.
Product code: NJT Immunohistochemistry Reagents And Kits
Reason for recall: These Lot numbers are not stable up to the expiry date on the product labeling.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Leica sent a MEDICAL DEVICE RECALL NOTIFICATION letter dated September 3, 2015 via mail to all of the consignees. The letter identified the affected, product, problem and actions to be taken. Customers are instructed to discontinue use of the reagent lots listed in the recall notification. It is requested that customers appropriately destroy any unused or partially used affected lots of the reagent, and indicate on the attached Medical Device Recall Notification Acknowledgement Form that this action has been undertaken. Customers were asked to confirm receipt of the notice as soon as possible by signing and dating the attached Medical Device Recall Notification Acknowledgement Form and fax it back to1-847-236-3747, to receive your alternative replacement for applicable orders. For questions contact your local Leica representative.
Quantity in commerce: U.S: 1 unit of CD10-270-CE-S & 66 units of CD10-270-CE. Foreign: 83 units of CD10-270-CE-S & 219 units of CD10-270-CE
Distribution: Worldwide Distribution - US Nationwide, Australia, Austria, Brazil, Canada, China, Czech Republic, Finland, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Netherlands, Norway, Romania, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland and UK.
Product codes and lots: CD10-270-CE-S (0.1 ml) 6033086 (U.S. Distribution) expire 06/2016, 6032390 expires 04/2016, 6033622 expires 07/2016. CD10-270-CE (1ml) 6032742 (U.S. Distribution) expires 11/2017.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0341-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0341-2016	Class II	Terminated	Voluntary: Firm initiated	2015-12-02	2015-11-25

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)