Abbott Diagnostic International, Ltd.: Abbott AxSYM Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of pretreatment solution and one bottle of gentamicin flourescein tracer. Abbott Laboratories, Abbott Park, IL 60064

Recall number

Z-0930-2008

Recalling firm

Abbott Diagnostic International, Ltd.

Product

Abbott AxSYM Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of pretreatment solution and one bottle of gentamicin flourescein tracer. Abbott Laboratories, Abbott Park, IL 60064

Status

Terminated

Initiated

2007-10-26

Posted

2008-02-26

Terminated

2012-07-30

Reason

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.

Root cause

Other

Action

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.

Quantity

3787 kits

Distribution

Worldwide, USA including states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, Hawaii and Puerto Rico, an countries of Canada, Mexico, Guatemala, Germany, Australia, Japan, Singapore, Hong Kong, Taiwan, South Korea, and New Zeland.

Lot, serial or model codes

List # 7A65-20 Lots # 53190Q100 Exp Date 04/12/08 and Lot # 53190Q101 Exp Date 04/12/08

510(k) numbers

["K935376"]

PMA numbers

not on file

Product code

LCD

Firm FEI

2623532

Firm city

Barceloneta

Firm state

PR

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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