Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila Abbott TDx/TDxFLx Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and one bottle of pretreatment solution. Abbott Laboratories, Abbott Park, IL 60064 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Abbott TDx/TDxFLx Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and one bottle of pretreatment solution. Abbott Laboratories, Abbott Park, IL 60064
Brand
Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila
Lot Codes / Batch Numbers
List # 9512-60 / Lot # 51187Q100 Exp Date: 09/17/08
Products Sold
List # 9512-60 / Lot # 51187Q100 Exp Date: 09/17/08
Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila is recalling Abbott TDx/TDxFLx Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent syste due to Incorrect Results -- Through evaluation of stability, Abbott have found a decrease in the calibrator A to F span with these reagents lots, which may p. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AK, AZ, AR, CA, CO, CT, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, VA, WA, WV, WI, PR
Page updated: Jan 10, 2026