FDA Medical Device Recalls (openFDA)
Leica Microsystems, Inc.: 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.
- Recall number
- Z-0341-2016
- 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.
- Status
- Terminated
- Initiated
- 2015-09-03
- Posted
- 2015-11-25
- Terminated
- 2017-11-30
- Reason
- These Lot numbers are not stable up to the expiry date on the product labeling.
- 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
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NJT
- Firm FEI
- 3000210133
- Firm city
- Buffalo Grove
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28