FDA Devices recall · Reported March 18, 2015
Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.
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 slid…
Dako North America Inc. recalled Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400… - a moderate-severity action.
Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400… was recalled by Dako North America Inc. in March 18, 2015. Reason: A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopcock componen…. Check the official notice for the remedy. Verify recall #Z-1261-2015 with the FDA Devices before acting.
The recall
Dako North America Inc. issued this moderate-severity FDA Devices recall-A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopcock componen….
- Moderate
- severity level
- 409 units
- affected scope
- Class II
- classification
- March 18, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1261-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1261-2015) was formally reported on March 18, 2015, with the manufacturer initiating the action on February 12, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Dako North America Inc. is listed as the recalling firm, operating out of Carpinteria, CA. Federal records list the affected scope as 409.
The documented reason for this recall is: 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 loc… Distribution data in the federal record shows the product reached: 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.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800). Automated slide stainer for in vitro diagnostic use.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1261-2015 |
| Date reported | March 18, 2015 |
| Date initiated | February 12, 2015 |
| Recalling firm | Dako North America Inc. |
| Firm location | Carpinteria, CA |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1261-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Methodology · Corrections · Archive as of August 2026