Retiro De Equipo (Recall) de TDx/TDxFLx Gentamicin Reagent

Recall

46146

Class 2

Z-0928-2008

2007-10-26

2008-02-26

Terminated

United States

2012-07-30

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66879

Incorrect results -- through evaluation of stability, abbott have found a decrease in the calibrator a to f span with these reagents lots, which may produce the following results: - printed error code "span less than min span" - controls out of range. when a control is out of range, patient results should not be reported.

Letters were sent to customers by Federal Express Priority mail on October 26, 2007. Two unique customer letters were sent. One letter was delivered to TDxlTDxFLx customers who received shipment oflots 5ll87Q100 and 51189QI00 and a second letter was delivered to AxSYM customers who received lots 53190QI00 and 53190QI01. Two letters were written because the actions required by the customer differ for the AxSYM and TDxlTDxFLx platforms. TDx/TDxFLx customers " Customer Letter (Product Recall) " Customer Reply Form AxSYM Customers " Customer Letter (Product Correction) " Customer Reply Form The Customers were instructed the following: TDx/TDxFLx Gentamacin Reagents " Discontinue use of and destroy TDx/TDxFLx reagent lots 51187Q 1 00 and 51189QI00. " Document the number of kits discarded for your records. Abbott will provide reimbursement for your destroyed kits. " If customers have forwarded any of the affected lots to another laboratory, to provide the laboratory with a copy of the communication. AxSYM Gentamicin Reagents " Revise the expiration date for lots 53190Ql 00 and 53190QI0l from 4/12/08 to 11/30/2007. " Run each level of control with each AxSYM Gentamicin sample or batch of samples. " If customers have forwarded any of the affected lots to another laboratory, to provide the laboratory with a copy of the communication.