CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory to the CoverStainer instrument. The purpose is to ho

FDA device recall Z-0563-2013 · posted 2012-12-19 · Terminated

Recall details

Recalling firm

Dako Denmark A/S

Reason for recall

The expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements, originating from variations in the manufacturing process.

Action taken

Dako sent a Voluntary Product Recall Notification dated November 13, 2012, to all affected customers. This voluntary recall notification was initiated because the expected life time of the CoverStainer slide racks (CS 10330) does not meet established performance requirements, originating from variations in the manufacturing process. The result can be that slides are falling out of the rack during the staining process. While this has been observed at only a few customer sites, the corrective action includes all CoverStainer installations. Customers were notified that Dako would correct the rack situation by using a new manufacturer and has imroved the rack design. Customers with questions were instructed to contact their local Dako representative. For questions regarding this recall call 805-566-3036.

Root cause

Device Design

Status

Terminated

Product code

KPA

Quantity affected

25 Units US (50-100 racks per unit) 106 total

Distribution

Worldwide Distribution - USA (nationwide) and the following countries: Australia France Rep. of Korea Belgium Germany Russia Brazil Israel Saudi Arabia Canada Italy Spain Chile Japan Sweden China Mexi

Date initiated

2012-11-26

Date posted

2012-12-19

Date terminated

2013-05-14

Location

Glostrup, Denmark