Radiometer Medical ApS: 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+, cN

Hazard

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.

Details from the source

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. Distribution: 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, Chil Quantity: 27,127 analyzers Lot/code info: Model Numbers: 393-800 and 393-801 Part Numbers/Serial Numbers/UDI(-DI) codes: ABL825 754R0100N003 754R0100N003 ABL825 754R0241N010 754R0241N010 ABL825 754R0334N006 754R0334N006 ABL825 754R0417N008 754R0417N008 ABL825 754R0449N004 754R0449N004 ABL825 754R0487N004 754R0487N004 ABL837 754R0631N006 754R0631N006 ABL825 754R0755N003 754R0755N003 ABL825 754R0757N007 754R0757N007 ABL825 754R0884N007 754R0884N007 ABL825 754R0917N002 754R0917N002 ABL825 754R0918N007 754R0918N007 ABL810 754R0941N008 754R0941N008 ABL827 754R1001N004 (01)05700693938004(10)754R1001N004 ABL805 754R1028N005 754R1028N005 ABL825 754R1105N005 754R1105N005 ABL825 754R1157N006 754R1157N006 ABL825 754R1204N006 754R1204N006 ABL805 754R1209N005 754R1209N005 ABL825 754R1220N003 754R1220N003 ABL805 754R1222N005 754R1222N005 ABL805 754R1222N006 754R1222N006 ABL825 754R1222N009 754R1222N009 ABL825 754R1223N008 754R1223N008 ABL805 754R1226N007 754R1226N007 ABL825 754R1234N003 754R1234N003 ABL825 754R1238N009 754R1238N009 ABL825 754R1238N011 754R1238N011 ABL825 754R1239N007 754R1239N007 ABL825 754R1239N009 754R1239N009 ABL825 754R1239N010 754R1239N010 ABL820 754R1240N011 754R1240N011 ABL825 754R1261N006 754R1261N006 ABL825 754R1262N007 754R1262N007 ABL825 754R1266N006 754R1266N006 ABL825 754R1267N003 754R1267N003 ABL805 754R1291N003 754R1291N003 ABL835 754R1371N011 754R1371N011 ABL835 754R1377N002 754R1377N002 ABL827 754R1404N002 (01)05700693938004(10)754R1404N002 ABL825 754R1427N003 754R1427N003 ABL805 754R1427N007 754R

UPC codes

05700693938004

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.