Recall Z-0491-2018 ยท KHO Fluorometer, For Clinical Use
Tosoh Bioscience Inc
TosohAutomated Enzyme Immunoassay Analyzer AIA-900, Product Catalog No. 022930. Product Usage: The AIA-900 Automated Enzyme Immunoassay System is an automated analyzer for in vitro diagnostic use that measures a variety of substances in serum, plasma, and or urine using the AIA-PACK reagent series.
| Date | Jun 11, 2017 |
| Status | Terminated |
| Reason | This recall has been initiated due to a potential malfunction of the photo interrupter (Pl). The potential malfunction has been attributed to aging and premature deterioration of the Pl collector current. |
| Root cause | Nonconforming Material/Component |
| Action | Customers were sent a recall notification by email on July 11, 2017 informing them that their local Field Service Engineer would contact them to make arrangements to proactively replace the affected parts. Follow up notifications will be by Federal Express with verification of delivery. |
| Quantity | 565 total devices U.S. |
| Distribution | Worldwide Distribution - U.S. Nationwide - Latin America |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.