Z-0341-2016 Class II Terminated
FDA device recall Z-0341-2016 was initiated by Leica Microsystems, Inc. on Sep 3, 2015 and is designated Class II. Reason for recall: These Lot numbers are not stable up to the expiry date on the product labeling. The recall status is terminated (terminated Nov 30, 2017). Affected 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.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 2, 2015
- Initiation Date
- Sep 3, 2015
- Termination Date
- Nov 30, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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
Product Description
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.
Reason for Recall
These Lot numbers are not stable up to the expiry date on the product labeling.
Distribution Pattern
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.
Code Information
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0341-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026