Z-1261-2015Class II

Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer...

Name: Z-1261-2015 Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer...
Creator: Dako North America Inc.
Published: 2015-02-12
License: https://open.fda.gov/license/

Agilent Technologies, Inc. / initiated 2015-02-12 / Terminated / root cause: manufacturing process

FDA source

Dako North America Inc. began a recall of Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro... on 2015-02-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1261-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-12
Posted: 2015-03-16
Terminated: 2016-02-11
Recalling firm: Agilent Technologies, 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.
Product code: KPA Slide Stainer, Automated
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1261-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1261-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-18	2015-03-10

Product code KPA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)