Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-

FDA device recall Z-0341-2016 · posted 2015-11-25 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

Reason for recall

These Lot numbers are not stable up to the expiry date on the product labeling.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

NJT

Quantity affected

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, Rom

Date initiated

2015-09-03

Date posted

2015-11-25

Date terminated

2017-11-30

Location

Buffalo Grove, IL