Dako Autostainer instruments: Autostainer Link 48, Model AS480; Autostainer Plus Link Instrument, Model AS100; Autostainer, Model S3400; and Autostainer Plus, Model S3800.
Check against the official notice below — it lists the full affected range.
Dako Denmark A/S recalled 796 Autostainer instruments across four models (Autostainer Link 48 Model AS480, Autostainer Plus Link Model AS100, Autostainer Model S3400, and Autostainer Plus Model S3800) distributed nationwide in the United States, to the U.S. government and military, and internationally to over 40 countries. The instruments recalled were manufactured between July 22, 1997 and June 28, 2018 and lack an installed syringe tray.
The hazard is that without the syringe tray, excess buffer may be applied to multiple slides, potentially causing false negative staining results if buffer or reagents leak. An updated Basic User Guide will help reduce the risk of false negative results from leakage. The source does not specify a remedy for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The Autostainer instrument may not have a syringe tray installed which could result in a small volume of excess buffer being applied to several slides. In addition to the syringe tray, the updated Basic User Guide will reduce the potential risk of false negative results in the case of leakage of buffer and/or reagents that may impact staining.
Reason for recall: The Autostainer instrument may not have a syringe tray installed which could result in a small volume of excess buffer being applied to several slides. In addition to the syringe tray, the updated Basic User Guide will reduce the potential risk of false negative results in the case of leakage of buffer and/or reagents that may impact staining. Distribution: Distribution was nationwide. There was government/military distribution. Foreign distribution was made to Canada, Australia, Bangaladesh, Belarus, Brazil, Bulgaria, Chile, China, Colombia, Croatia, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Macedonia, Morocco, New Zealand, Norway, Quantity: 796 devices Lot/code info: All serial numbers of devices manufactured between 7/22/1997-6/28/2018 that do not have an installed syringe tray, UDI 05700572035497.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.