Recall Z-0491-2018— Tosoh Bioscience Inc
Class II · Terminated
Class II FDA medical device recall by Tosoh Bioscience Inc, initiated 2017-06-11, terminated 2019-12-31. FDA's recall record names no specific 510(k) clearance for this event. Product: Tosoh¿Automated 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.. 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..
- Recalling firm
- Tosoh Bioscience Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-11
- Terminated
- 2019-12-31
- Firm location
- Grove City, OH, United States
Product description
Tosoh¿Automated 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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.