Device Recall Sm ELISA Test System 의 리콜

Recall

49438

Class 2

Z-1089-2009

2008-08-19

2009-03-31

Terminated

United States

2009-04-30

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73329

The calibrator value is printed incorrectly on the sm elisa test system, lot # 08041819. the calibrator value (cv) printed on the label is 102; the correct cv should read 266.

Urgent Recall Notice letters were sent out by Federal Express night mail on August 19, 2008 to all direct account. Wampole (Inverness) will notify their customers in a separate letter. Recall letters explained the reason for the recall and that the product does meet the company's criteria when it is used qualitatively to interpret index values or OD rations as outlined in the kit package insert. Customers are advised in the letter that the Calibrator Value of 102 is incorrect and that it should be 266. Instructions to correctly express the specimen results using specimen and calibrator OD values semi-qualitatively as Unit Values and the Calibrator Value (CV) or 266 are included. Letters also state that results for all patients using the incorrect CV of 102 should be recalculated using the correct CV of 266. All letters included a fax back form indicating that they have received the recall notification, have notified customers to correct the CV value for the Semi-Quantitative Conversion and have notified customers that have received the kit to correct the Semi-Quantitative Conversion of Optical Density to AAU/mL for the affected lot number of the Sm ELISA Test System.