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U.S. Department of Health and Human Services

Class 2 Device Recall Abbott Laboratories HbA1c Calibrators

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  Class 2 Device Recall Abbott Laboratories HbA1c Calibrators see related information
Date Initiated by Firm April 30, 2014
Date Posted October 24, 2014
Recall Status1 Terminated 3 on December 28, 2016
Recall Number Z-0135-2015
Recall Event ID 68201
510(K)Number K130255  
Product Classification Single (specified) analyte controls (assayed and unassayed) - Product Code JJX
Product HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators (lyophilized) contain hemoglobin and glycated hemoglobin from human whole blood. Prior to lyophilization, the calibrator matrix is an MES-buffered solution. Preservative: Ofloxacin.

For use in the calibration of the Hemoglobin A1c assay on the ARCHITECT c 8000 and c 4000 Systems.
Code Information List Number: 4P52-02;  Lot Number: 45063UQ12;  Expiration Date: 15 DEC 2014
Recalling Firm/
Manufacturer		 Abbott Laboratories
100 Abbott Park Rd
Abbott Park IL 60064-3502
Manufacturer Reason
for Recall		 HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calibrator lot. If calibrator lot 45063UQ12 is used in the calibration of the HbA1c assay using values from an incorrect calibrator value sheet then all results, including quality control and patient, may be falsely elevated.
FDA Determined
Cause 2		 Under Investigation by firm
Action Product Correction letters dated April 30, 2014 were sent to all customers. The letters included isntructions for customers to: 1) verify that the lot numbr listed on each calibrator bottle agrees with the lot number printed on the value sheet; 2) If HbA1c Calibrators lot 45063UQ12 has already been utilized in your laboratory, verify the concentrations configured for this calibrator lot match the values in the letter; 3) If these do not match, use the values in the letter when calibrating the HbA1c assay using calibrator lot 45063UQ12; and, 4) follow your laboratory protocol regarding the need for reviewing previously reported patient results if incorrect calibrator values were used.
Quantity in Commerce 183 calibrator kits
Distribution Worldwide Distribution in the countries of Austria, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Italy, Kuwait, Malaysia, Norway, Poland, Romania, Russia, Saudi Arabia, Thailand, Turkey, and United Arab Emirates.
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 = JJX and Original Applicant = ABBOTT LABORATORIES
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