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U.S. Department of Health and Human Services

Class 2 Device Recall ABL7XX Calibration 1 Solution S1720

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  Class 2 Device Recall ABL7XX Calibration 1 Solution S1720 see related information
Date Initiated by Firm September 05, 2008
Date Posted December 03, 2008
Recall Status1 Terminated 3 on April 25, 2012
Recall Number Z-0457-2009
Recall Event ID 49468
510(K)Number K002290  
Product Classification Ion Specific Calcium Electrode - Product Code JFP
Product ABL7XX Calibration 1 Solution S1720. P/N S1720, 944-024

Intended for in vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, potassium, sodium, calcium, chloride, glucose, lactate, total bilirubin, and co-oximetry parameters (total hemoglobin, oxygen saturation, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb, FHbF). Also, intended for in vitro testing of samples of expired air for the parameters pO2 and pCO2.
Code Information P/N S1720, 944-024; Lot: WA-04
Recalling Firm/
Manufacturer		 Radiometer America Inc
810 Sharon Dr
Westlake OH 44145
For Additional Information Contact Vincent Sigmund
440-871-8900 Ext. 209
Manufacturer Reason
for Recall		 The firm found that for this particular lot that the barcode, used for entering the characteristics of CAL1 Solution into the analyzer, does not reflect the actual values of the solution. As a consequence, the calibration curves for these parameters and thereby the measured results for patient samples and quality controls will be biased.
FDA Determined
Cause 2		 Process control
Action On, 9/2/2008 the firm sent out recall notification letters requesting their customers discard any Calibration 1 Solution (CAL1) S1720 (part number 944-024), lot WA-04, complete the attached return form and fax it to 800-736-0601. The firm will send out replacements for all affected product that the firm shows was shipped to their location. Further questions could be directed to Technical Support at 800-736-0600, option 2.
Quantity in Commerce 3,200/200ml bottles
Distribution Worldwide Distribution --- USA including states of AZ, CA, FL, IA, ID, IL, IN, KY, LA, MD, NC, ND, NE, NY, OH, OK, PA, SD, TX, VA, WA, and WI, and country of Canada.
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 = JFP and Original Applicant = RADIOMETER MEDICAL A/S
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