Recall Z-1877-2016
Leica Microsystems, Inc. · initiated April 5, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
Codes / lots: 1ml size Novocastr Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) with lot numbers 6032734, 6033766, 6037153 and 6039088.
Reason for recall
Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling.
FDA-determined cause: Nonconforming Material/Component
Action taken
An Urgent: Medical Device Recall Notification dated 4/5/2016 was sent to consignees with the affected lots of CDX2 and RCC marker. The customers were notified of the problems as well as the following actions to be taken by the consignees: Do not use or continue to use the reagent lots listed above, as they have the potential to result in inadequate tissue staining and lead to weak or false negative pathology results. Appropriately destroy any unused or partially used affected lots of the reagent Complete the attached Recall Notification Acknowledgement Form that this action has been undertaken. The firm also request that the notification is passed to all those within their organization who need to be aware of this issue. The firm requests consignees to return the completed acknowledgement form to LMGRA@Leica-Microsystems.com to receive credit for affected lots that have been destroyed by the consignees laboratory.
Details
- Recall number
- Z-1877-2016
- Initiated
- April 5, 2016
- Terminated
- November 30, 2017
- Product code
- NJT – Immunohistochemistry Reagents And Kits
- Quantity
- 90 Units
- Distribution
- Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.
- Recalling firm
- Leica Microsystems, Inc., Buffalo Grove, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1876-2016 Class II | Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is…Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the… | 04/05/2016Terminated |