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U.S. Department of Health and Human Services

Class 2 Device Recall ABL800 Series analyzer with FLEXQ module

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  Class 2 Device Recall ABL800 Series analyzer with FLEXQ module see related information
Date Initiated by Firm January 16, 2007
Date Posted April 06, 2007
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-0705-2007
Recall Event ID 37167
510(K)Number K043218  
Product Classification Analyzer; Blood gases - Product Code CHL
Product ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27
Code Information There are no specific lot codes. (devices equipped with software version 5.2 to 5.27)
Recalling Firm/
Manufacturer		 Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1598
For Additional Information Contact
440-871-8900
Manufacturer Reason
for Recall		 In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. This occurs when a Safe Pico blood sampler associated with a specific patient is pre-registered in the analyzer by scanning a barcode.
FDA Determined
Cause 2		 Other
Action Radiometer America issued a recall letter to their U.S. customers dated 1/16/2007. The letter informs the customers of this software anomaly and the conditions underwhich analyzer results can be stored with incorrect Patient Demographics. The letter goes on to inform the customers that a Radiometer Service Representative will be visiting each customer location shortly in order to upgrade the affected software. In the meantime, the letter recommends that the customer(s) not pre-register their samples. The letter is accompanied by an attached FAX FORM which the customer is asked to sign and complete in order to verify receipt of the recall letter and to fax back to the recalling firm.
Quantity in Commerce 64 in U.S. & 1,281 to foreign accounts
Distribution Worldwide Distribution-USA including states of NY, KS, SD, OH, TX, KY, NC, IL, MO, AL, UT, CO, CA, NM, and MI and Country of Denmark
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 = CHL and Original Applicant = RADIOMETER MEDICAL APS
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