Device Recall AEROSET, ARCHITECTURE C8000 & C16000 의 리콜

Recall

55700

Class 2

Z-2398-2010

2010-05-04

2010-09-10

Terminated

United States

2012-04-05

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91601

Product may give inaccurate results and aspiration errors with reagent configuration, including results outside of linear range & calibration failure.

Abbott Laboratories issued a "Product Recall: Immediate Action Required" letter dated May 4, 2010 to consignees. The letter described the product, problem and action to be taken by the customer. The letter instructed the customer to: 1) Identify affected product in inventory 2) Discontinue use and destroy any remaining inventory of the affected lot: 7D71-21 3) Complete and return an enclosed Customer Reply Form 4) Order alternative kit sizes for Clinical Chemistry Phosphorus: LN 7D71-31 or 7D71-22 5) For AEROSET Systems, manually update parameters as described in the letter. 6) For ARCHITECT cSystems, implement alternative kit sizes without system changes. 7) Provide a copy of the letter to other laboratories that have been distributed the affected product. US customers can contact Abbott Customer Service at 1-877-4ABBOTT. Customers outside the U>S> are instructed to contact their local area Customer Service.