ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) " In vitro testing of samples of expired air for the parameters pO2 and pCO2 " In vitro testing of pleura samples for the pH parameter.
Recall
- Recall Number
- Z-2426-2024
- Event Number
- 94771
- Firm
- Radiometer Medical ApS Akandevej 21 Bronshoj Denmark
- FEI Number
- 3002807968
- Product Code
- CHL
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- May 31, 2024
- Posted
- July 24, 2024
Description
ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing of samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl , cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) " In vitro testing of samples of expired air for the parameters pO2 and pCO2 " In vitro testing of pleura samples for the pH parameter.
Issue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the calibration solution bottles. This may result in a probability of reporting biased out-of-specification pH results on blood samples.
On 6/10/2024, the firm send an "URGENT: MEDICAL DEVICE RECALL" Letter to customer informing them that an internal technical study was carried out based on reports from internal and external users regarding pH sensitivity and pH drift errors for calibrations and measured QC pH values out of range. The study concludes that there is a possibility of reporting biased out-of-specification pH results on blood samples. This may occur if the calibration solution's pH value decreases during the in-use period due to bacterial growth in the calibration solution bottles CAL1 and/or CAL2. Customers are instructed to: -Immediately you implement either "Procedure 1" for customers who run daily quality controls or "Procedure 2" for customers who do not. The procedures are described on the subsequent pages of the Recall letter. This must be carried out regardless of which patient groups are measured on the analyzer. It will ensure that biased out-of-specification pH results that may lead to the risks above are not reported. PROCEDURE 1, for customers who run daily quality controls The individual steps of the procedures are described in the Operators Manual - Troubleshooting Messages (chapter 11). PROCEDURE 2, for customers who do not run daily quality controls The individual steps of the procedures are described in the Operators Manual - Troubleshooting Messages (chapter 11). For questions/assistance, contact the firm at 1-800-736-0600, Monday - Friday 9am to 7pm (EST).
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27,127 analyzers