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U.S. Department of Health and Human Services

Class 2 Device Recall reference electrode membranes / A8L8X7 Flex Creatinine Analyzer

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 Class 2 Device Recall reference electrode membranes / A8L8X7 Flex Creatinine Analyzersee related information
Date Initiated by FirmMarch 26, 2009
Date PostedMarch 05, 2010
Recall Status1 Terminated 3 on May 09, 2012
Recall NumberZ-1015-2010
Recall Event ID 51983
510(K)NumberK051968 
Product Classification Analyzer, enzyme, for clinical use - Product Code CGL
ProductReference Electrode Membranes for use with blood gas analyzer ABL 800 FLEX, when used on ABL 827 and ABL 837 with Creatinine modules (8x7). The device is packaged four (4) units per box.
Code Information Part Number: 942-058, Article Number: D711
FEI Number 1523456
Recalling Firm/
Manufacturer		 Radiometer America Inc
810 Sharon Dr
Westlake OH 44145
For Additional Information Contact
440-871-8900 Ext. 209
Manufacturer Reason
for Recall		Analysis of customer data, (for ABL 8X7 customers) has shown that the reference membranes are out of analytical specifications when replaced as specified in the device labeling. These errors in analytical specifications could lead to inadequate or clinical interventions (therapy) or misleading interpretation of patient status in clinical settings.
FDA Determined
Cause 2		Other
ActionThe recalling firm contacted their customers and notified them of this recall with a letter on 3/26/2009. The letter informs the customer that Radiometer has determined that the Reference Membrane D711 for use in the ABL8x7 Flex Creatinine Analyzer has a shorter in-use lifetime than the previously recommended 1-month interval listed in the Operators Manual. It states that consequently, the firm has changed the recommended replacement intervals as they correspond to the number of samples per day analyzed by the customer and a revised insert is being supplied to the customer which should be placed in the Operators Manual to reflect this new information. The recall notification is also accompanied by an attached response FAX FORM which the customer is asked to complete and to fax back to Radiometer so as to acknowledge receipt of the recall notification letter and the revised insert. Please direct questions to the company TechLine at 1-8007360600 opt 2.
Quantity in Commerce50 membranes in U. S. distribution
DistributionThe recalled product was distributed customers located in the following states within the U.S.: CT, FL, GA, IL, MA, MD, MN, MO, NC, NM, OH, PA, VA, WA, WI, and WV. Product was also sold in the following countries: Algeria, Australia, Austria, Bahrain, Brazil, Czech Rep., Denmark, England, Estonia, France, Germany, Greece, Hungary, India, Italy, Japan, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland & Turkey.
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 = CGL
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