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U.S. Department of Health and Human Services

Class 2 Device Recall AxSym Gentamicin Reagent

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 Class 2 Device Recall AxSym Gentamicin Reagentsee related information
Date Initiated by FirmOctober 26, 2007
Date PostedFebruary 26, 2008
Recall Status1 Terminated 3 on July 30, 2012
Recall NumberZ-0930-2008
Recall Event ID 46146
510(K)NumberK935376 
Product Classification Enzyme Immunoassay, Gentamicin - Product Code LCD
ProductAbbott 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
Code Information List # 7A65-20 Lots # 53190Q100 Exp Date 04/12/08 and Lot # 53190Q101 Exp Date 04/12/08
Recalling Firm/
Manufacturer
Abbott Diagnostic International, Ltd.
Carr # 2 Km 58.0
Cruce Davila
Barceloneta PR 00617-3009
For Additional Information ContactSaritza Rios
787-846-3500
Manufacturer Reason
for Recall
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.
FDA Determined
Cause 2
Other
ActionLetters 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 in Commerce3787 kits
DistributionWorldwide, 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.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LCD
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