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U.S. Department of Health and Human Services

Class 2 Device Recall IMx Theophylline Reagent Pack In Vitro Test

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  Class 2 Device Recall IMx Theophylline Reagent Pack In Vitro Test see related information
Date Initiated by Firm April 11, 2007
Date Posted July 03, 2007
Recall Status1 Terminated 3 on June 10, 2011
Recall Number Z-0958-2007
Recall Event ID 37957
510(K)Number K833070  
Product Classification Theophylline Reagent - Product Code LER
Product IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test.
This reagent system is composed of one bottle of Theophylline Pretreatment Solution, one bottle of Theophylline Antiserum (Mouse Monoclonal) and one bottle of Theophylline Fluorescein Tracer.
Code Information Lot #41610Q100; Expiration date 04/25/2008
Recalling Firm/
Abbott Diagnostic International, Ltd.
30 Bo Cruce Davila
Barceloneta PR 00617-3009
Manufacturer Reason
for Recall
A decrease in mP values (calibration curve Net Polarization value) has been observed with this reagent lot at all calibrator levels and may produce the following results: Calibration Error Code 148 (Polarization Too Small), Calibration Error Code 172 (Calibration Not Stored or Calibration Not Accepted) Controls out of range (when using a stored calibration curve).
FDA Determined
Cause 2
Action An April 11, 2007, Product Recall Letter was sent to all customers who received the affected lot. All customers who received the affected lot will be contacted. The following communication types were used: Product Recall Letter & Customer Reply Form. Letters were sent to customers by Federal Express Priority mail. The Customers were instructed the following: To discontinue use of and destroy IMx Theophylline reagent lot 41610QI00. If they had forwarded the lots listed in the Product Recall letter to other laboratories, they were instructed to inform them of this Product Recall and provide a copy of this letter to them. They also we instructed to retain a copy of the communication for their records
Quantity in Commerce 17 Kits
Distribution Worldwide: CA, IL, MA, NY, OR, PA, VA, and WV and countries of Germany and Singapore
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LER and Original Applicant = ABBOTT LABORATORIES