Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic

FDA device recall Z-0808-2016 · posted 2016-02-12 · Terminated

Recall details

Recalling firm

Leica Microsystems, Inc.

Reason for recall

The Firm informed the importer/distributor, Leica Microsystems, a manufacturing error occurred during the filling of some containers of the Bond Polymer Refine Red Detection DS9390 kits, which may result in inadequate staining.

Action taken

Leica Biosystems sent an Urgent Medical Device Recall Notice dated November 30, 2015, to all affected customer. The letter identified the product the problem and the action needed to be taken by the customer. 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. Please also properly destroy any unused or partially used affected lots of the reagent, and indicate by signing and returning the attached Medical Device Recall Acknowledgement Form that this action has been undertaken. As indicated in the Instructions for Use, the clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologist. The consignees are requested to consult with their laboratory director and physician to determine whether a review of past results obtained from the affected lots is clinically warranted. Direct accounts are requested to forward the notice primarily to the end users where the product has been sold and to all those within the organization who need to be aware of this issue. Periodic effectiveness checks will be conducted to address non responders. For further questions please call ( 847) 405-5413

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

NJT

Quantity affected

3745

Distribution

Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Argentina, Australia, Austria, Belgium, Chile, Denmark, France, Germany, Greece, Hong Kong, Italy, Japan , Netherlands,

Date initiated

2015-11-27

Date posted

2016-02-12

Date terminated

2017-01-05

Location

Buffalo Grove, IL