ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Model number 393-090 (instrument). The affected analyzers are serial numbers 393-090R0027N001 to present.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Radiometer America Inc
- Reason for Recall:
- The ABL90 analyzer does not always use the most recent calibration data to calculate patient results. This can in some cases lead to a biased patient result.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
ABL90 FLEX analyzer; Model number 393-090. A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.
Product Codes/Lot Numbers:
Model number 393-090 (instrument). The affected analyzers are serial numbers 393-090R0027N001 to present.
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1046-2015
Related Recalls
ABL90 FLEX Analyzer REF 393090 UDI:05700693930909
Radiometer America
Software Security; The action is being initiated because of software security vulnerabilities with the firm's analyzer operating system, which may cause the device to shutdown or reboot resulting in delayed medical treatment.
From three incidents in Denmark and Sweden, comparison studies on patient blood samples carried out for quality assurance demonstrated that creatinine measurements as determined on analyzers could be underestimated with up to 28% as compared with measurements from COBAS. The underestimated creatinine occurs specifically, when measurements on Autocheck 6+ level 1 (also known as S7835 Autocheck module and abbreviated AC6+L1) are less than or equal to 230 micro-meter of a specified insert interval for AC6+L1 with insert limits 210 290 micro-meter. Ultimately, a lower read-out on patient samples is observed Customers are concerned about underestimation of creatinine results in patients, which are to undergo radiocontrast x-ray investigations. If these patients are not healthy, the exposure of radiocontrast agents may induce kidney insufficiency (contrast-induced nephropathy). Hazardous situation: Underestimation of the concentration of creatinine.
ABL800 analyzer, model numbers 393-800 and 393-801.
Radiometer America
The analyzer software may cause a mis-match of patient demographics and test results when a certain sequence of events occur.