Recall Z-0600-2019 ยท KHO Fluorometer, For Clinical Use
Tosoh Bioscience Inc
AIA-900Analyzer, Product code 022930, 022930R The AIA-2000 analyzer and AIA-900 analyzer are capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay.
| Date | Sep 28, 2018 |
| Status | Terminated |
| Reason | Tosoh Bioscience has become aware of a potential issue with the AIA-900 and AIA-2000 analyzers that could result in slippage of the incubator unit contained within the system. If the tension of the timing belt is not adjusted correctly, it is possible for a misalignment that will result in a mechanical error. Tosoh has taken the required actions to inspect the tension of the timing belt during preventative maintenance and correct the instruments where this issue has been observed. If incubator slippage occurs, the unit will cease to function, and a system error will be reported. If this occu |
| Root cause | Process control |
| Action | On September 28, 2018, the firm, Tosoh Bioscience, notified consignees via an "URGENT: MEDICAL DEVICE RECALL" letter. The letter described the product, problem and actions to be taken. The letter informed customers that the AIA-900 and AIA -2000 analyzers had a potential issue that could result in slippage of the incubator unit within the system. Immediate Actions to be taken by the Customer/User " Thoroughly review the content of this letter. " Continue to use your Instrument. o Contact Tosoh Technical Support if mechanical errors occur. o The tension of the timing belt will be assessed and |
| Quantity | 395 |
| Distribution | US Nationwide distribution and International distribution to Colombia, Chile, Honduras, Cayman Islands, Panama, Costa Rica, Guatemala, Venezuela, Uruguay, Peru, and Ecuador. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.