Date Initiated by Firm | July 03, 2018 |
Create Date | December 22, 2018 |
Recall Status1 |
Terminated 3 on August 30, 2023 |
Recall Number | Z-0682-2019 |
Recall Event ID |
81547 |
510(K)Number | K041874 |
Product Classification |
Electrode measurement, blood-gases (pco2, po2) and blood ph - Product Code CHL
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Product | ABL800 analyzer, model numbers 393-800 and 393-801. |
Code Information |
Model 393-800 ABL800 Series w/o Creatinin (All serial numbers) for the following configurations: ABL800, ABL805, ABL810, ABL815, ABL820, ABL825, ABL830, and ABL835. Model 393-801 ABL800 Series with Creatinin (All serial numbers) for the following configurations: ABL817, ABL827, and ABL837. |
Recalling Firm/ Manufacturer |
Radiometer America Inc 250 S Kraemer Blvd Brea CA 92821-6232
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For Additional Information Contact | Technical Support 800-736-0600 Ext. 1 |
Manufacturer Reason for Recall | The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur. |
FDA Determined Cause 2 | Software design |
Action | The recalling firm issued letters dated 7/3/2018 on 7/3/2018 via FedEx. |
Quantity in Commerce | 2,131 analyzers |
Distribution | Distribution was nationwide. There was also military/government distribution. Foreign distribution was made to Canada. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = CHL
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