Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.
This recall has been terminated (originally issued March 22, 2016).
- Company
- Leica Microsystems, Inc.
- Recall Initiated
- March 22, 2016
- Terminated
- November 30, 2017
- Recall Number
- Z-1704-2016
- Quantity
- 290 units
- Firm Location
- Buffalo Grove, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining.
Distribution
Worldwide Distribution -- U.S., to the following states: AK, CA, FL, GA, MN, MT, NJ, OH, TX and WA; and, the country of Canada.
Lot / Code Info
Lot numbers: 6025204, 6029060, 6029949, 6035923 and 6036060.
Root Cause
Nonconforming Material/Component
Action Taken
A Medical Device Recall Notification letter was sent via e-mail on April 5, 2015 to the consignees describing the nature of the recall and action that needed to be taken. The firm requested that the consignees take the following actions: Only use Novocastra Liquid Mouse Monoclonal Antibody Calretinin with the lot numbers of diluent specified. There is no need for retrospective review of tissue staining if appropriate positive controls were properly used and interpreted during the immuno / in situ staining. Complete and return the attached acknowledgment. The firm requests that consignees contact their local Leica representative if they have any questions or concerns, or alternatively please contact the firm at the following e-mail address; LMGRA@leica-microsystems.com