Recall Z-0602-2019 ยท KHO Fluorometer, For Clinical Use
Tosoh Bioscience Inc
AIA-900 Automated Immunoassay Analyzer performs three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
| Date | Sep 28, 2017 |
| Status | Terminated |
| Reason | The firm has become aware of a potential issue that may affect the mixing motor drive harness and mixing home detection sensor relay harness on your AIA-900 Analyzer. It is possible that the harnesses could rub against the Plarail chain during operation and result in premature wear. If observed, this issue will cause the following system error to be reported D.lane Mix home overrun error [4093] . If observed, this issue will cause the AIA-900 Analyzer not to function and the D.lane Mix home overrun error [4093] will be reported by the system. Replacement of the motor drive harness and m |
| Root cause | Component design/selection |
| Action | On September 28, 2018, the firm notified customers via Urgent Medical Device Recall letter. Customers were informed of the potential issue. Immediate Actions to be taken by the Customer: Thoroughly review the content of this letter. " Identify if the serial number of your analyzer is listed in this notification. o If the serial number of your analyzer is listed: 1. At the next service call or scheduled PM, whichever occurs first, a Tosoh field service engineer will verify the motor drive harness and mixing home detection sensor relay harness are bundled together and placed into a double-coat |
| Quantity | 258 |
| Distribution | Nationwide distribution. Foreign distribution to Chile, Colombia, Ecuador, Guatemala, Honduras, Panama, Peru, Puerto Rico, Uruguay, and Venezuela. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.