Open, Classified

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.

FDA Recall Z-2426-2024 · Posted 2024-07-24

Recall StatusOpen, Classified

Product CodeCHL

Date Initiated2024-05-31

Product Quantity27,127 analyzers

Reason for Recall

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.

Firm Action

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).

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide - U.S. Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Canada, Afghanistan, Albania, Algeria, Argentina, Bahrain, Bangladesh, Belarus, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Chile, Colombia, Cuba, Cyprus, Dominican Republic, Ecuador, Egypt, Eritrea, Ethiopia, Greece, Guatemala, Honduras, Iraq, Iran, Israel, Jamaica, Jordan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Malta, Mauritius, Moldova, Nepal, Nicaragua, Nigeria, Oman, Pakistan, Paraguay, Peru, Philippines, Puerto Rico, Qatar, Romania, Saudi Arabia, Serbia, Slovenia, Sri Lanka, Suriname, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Uganda, Ukraine, United Arab Emirates, Uruguay, Uzbekistan, Venezuela, Vietnam, Yemen, Zimbabwe Australia, New Zealand, New Caledonia, Tokelau, Austria, Belgium, Netherlands, China, Croatia, Czech Republic, Slovakia, Denmark, Iceland, Finland, Estonia, France, Germany, Hong Kong, Hungary, India, Brunei, Italy, Japan, Kazakhstan, Malaysia, Mexico, Norway, Poland, Russia, Singapore, South Africa, Cameroon, Ivory Coast, Malawi, South Korea, Spain, Portugal, Sweden, Switzerland, Turkey, United Kingdom, Ireland.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041874ABL800 FLEXRadiometer Medical Aps · 2004-10-08

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.