Recall Z-1054-2012 ยท NJT Immunohistochemistry Reagents And Kits
Leica Microsystems, Inc.
Novocastra Liquid Concentrated Mouse Monoclonal Antibody CD7 (LP15) Reagent; an in vitro diagnostic primary antibody for use as part of an antibody panel for the classification of tumors of T-cell origin; Catalog No. NCL-L-CD7-580; packaged in 1 mL vials and 0.1 mL vials; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. NCL-L
| Date | Feb 17, 2012 (initiated Jan 10, 2012) |
| Status | Terminated |
| Reason | The primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15) have been adulterated. |
| Root cause | Labeling mix-ups |
| Action | Leica Microsystems, Inc. sent a Medical Device Field Notification letter dated January 4, 2012, via first class mail on January 10, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to discontinue use of the product and to return the product to the firm. Customers who have received the affected lot numbers of the listed products were requested to return any unused/part used reagents to the Buffalo Grove, IL, location for replacement. The accounts were asked to complete the attached Ackn |
| Quantity | 60 - 1 mL and 11 - 0.1 mL vials |
| Distribution | Worldwide Distribution -- USA (nationwide) and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.