Recall Z-1261-2015 ยท KPA Slide Stainer, Automated
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.
| Date | Mar 16, 2015 (initiated Feb 12, 2015) |
| Status | Terminated |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.