Date Initiated by Firm | January 18, 2008 |
Create Date | June 25, 2015 |
Recall Status1 |
Terminated 3 on February 24, 2012 |
Recall Number | Z-1653-2008 |
Recall Event ID |
46686 |
510(K)Number | K002290 |
Product Classification |
Human Blood Analyzer - Product Code CHL
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Product | ABL700 Series analyzer - Human Blood Analyzer (Laboratory Device). |
Code Information |
ABL700 Series (902-441) |
Recalling Firm/ Manufacturer |
Radiometer America Inc 810 Sharon Dr Westlake OH 44145-1598
|
For Additional Information Contact | Vincent Sigmund 440-871-8900 Ext. 209 |
Manufacturer Reason for Recall | Reported calibration errors are not displayed on the analyzers parameter bar screen or on the patient results when the calibration number is between 32768 - 65535 and 98303 - 131070. This may cause the operator to perform measurements and obtain questionable results. |
FDA Determined Cause 2 | Software design |
Action | On February 28, 2008, a Field Action Notes Letter was issued advising them about a Mandatory Software Update. Customers were notified of the problem by fax and letter (Fed Ex). The Recall Letter instructed the user to disable the parameter bar feature and only rely on the traffic light system indicator which properly indicates system errors. The letter includes instructions to temporarily fix the problem and notice of a update of the software module that updates the parameter bar. If you have any questions contact Vincent Sigmund at (440)-871-8900 ext. 209. |
Quantity in Commerce | 2481 Units |
Distribution | Worldwide Distribution - USA and Canada - Products were sold in all fifty (50) US States. including twenty-nine 29 government accounts and 138 Canadian accounts. |
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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