Dako North America Inc.: Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.

Recall number

Z-1261-2015

Recalling firm

Dako North America Inc.

Product

Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.

Status

Terminated

Initiated

2015-02-12

Posted

2015-03-16

Terminated

2016-02-11

Reason

A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopcock component may, in some circumstances, cause leakage of excess buffer onto slide location 34 on the AS480, or slide locations 35 and 36 on the AS100, S3400, and S3800. Affected dates are from 12/2013-08/2014.

Root cause

Nonconforming Material/Component

Action

The firm, Dako, sent an "Urgent Medical Device Recall Notification" letter dated 2/12/15 to customer on 02/12/15. The firm's letter advised customers to do the following: The firm stated that customers can continue to use the instrument however should take the following actions: - Discontinue to use the HercepTest on slide location 34 - As set forth in Dako's staining protocol, use on-slide positive controls and two drop zones - Watch for any indication of buffer leakage from they syringe assembly. This can be done easily when the tubes are checked for air bubbles in connection with exchange of the buffer bottle - Check for weak staining in regards to HercepTest in slide position 34. Dako's Actions: Dako states that a representative will contact the customers within the next few weeks in order to determine whether the HercepTest has been used for staining slides in position 34. The firm has identified a longer term corrective action plan of installing a drip tray under the stopcock and states that a representative will contact the customer when it is available. Transmission of Notice: The firm requests that customers inform those that need to be aware of the notification and to where the instruments might have been transferred to. The firm states that customers should ensure the organizations maintains awareness of the noticed and recommended steps until the corrective actions have been completed. The firm also asks customers to complete, sign, and return the attached recall form as soon as possible. On 02/23/15 the firm sent out a second notification letter to customers with the following additional recommendations: - Discontinue the use of HercepTest in slide location 34, 35, and 36 depending on the make and model of the instrument In addition the firm recommended that customers pay special attention to any indication that leakage has compromised staining. -When staining using the HercepTest protocols, excess leakage from the sy

Quantity

409

Distribution

Worldwide Distribution: US (nationwide) and countries of: AT, AU, BE, CA, CH, DE, DK, ES, FR, GB, IE, IT, JP, NL, NO, PL, and SE.

Lot, serial or model codes

992640 Rev. 02, 992085 Rev.no H, 992625 Rev.no F, 992326 Rev.no C  Affected dates: 12/2013-08/2014  Each device is labeled with a unique serial number.  Catalog/Model Number: - AS480 - S3800 - S3400 - AS100

510(k) numbers

not on file

PMA numbers

not on file

Product code

KPA

Firm FEI

2022180

Firm city

Carpinteria

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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