Radiometer America Inc

Model Number 942-073; all lots which have not expired their product lifetime which would be lot 972-073R0465 and onward: Affected lot numbers 942-073R0465 942-073R0468 942-073R0469 942-073R0470 942-073R0471 942-073R0472 942-073R0474 942-073R0475 942-073R0476 942-073R0478 942-073R0479 942-073R0480 942-073R0481 942-073R0482 942-073R0487 942-073R0488 942-073R0489 942-073R0490 942-073R0491 942-073R0492 942-073R0493 942-073R0494 942-073R0495 942-073R0496 942-073R0497 942-073R0498 942-073R0499 942-073R0500 942-073R0501 942-073R0502 942-073R0503 942-073R0504 942-073R0507 942-073R0509 942-073R0510 942-073R0511 942-073R0512 942-073R0513 942-073R0515 942-073R0518 942-073R0520 942-073R0521 942-073R0522 942-073R0523 942-073R0524 942-073R0525 942-073R0526 942-073R0527 942-073R0528 942-073R0529 942-073R0530 942-073R0532 942-073R0533 942-073R0534 942-073R0535 942-073R0536 942-073R0537 942-073R0538 942-073R0539 942-073R0540 942-073R0541 942-073R0542 942-073R0544 942-073R0545 942-073R0546 942-073R0548 942-073R0549 942-073R0550 942-073R0551 942-073R0553 942-073R0555 942-073R0556 942-073R0557 942-073R0558 942-073R0560 942-073R0561 942-073R0562 942-073R0564 942-073R0565 942-073R0566 942-073R0567 942-073R0569 And onwards: The firm is still determining the scope of how many lot numbers are affected.

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA including NM, NC, TN, OH, NE, CA, MO, GA, MA, TX, WV, PA, NY, VA, MN, IN, ME, MD, IL, MI, KS, WI, FL, WA, CT, OK, CO, and Internationally to Canada, Denmark, Spain, Italy, India, Sweden, Germany, Australia, Hungary, Great Britain, Norway, Uruguay, France, Poland, Switerland, Russian Federation, Netherlands, Czech Republic, Mexico, Brazil, Czechoslovakia, Austria, Singapore, Syria, Phillipines, Egypt, Bolivia, Japan, New Zealand, Turkey, Saudi Arabia, Algeria, Qatar, and Finland.

Crea A and B membranes, packaged 4 per box || Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of samples of whole blood for the parameters 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.

Model Number 110705:  Lot numbers: 1310500, 1310501, 1310502, 1310503, 1310518, 1310519, 1310520, 1310521, 1310767, 1310768, 1310769, 1310770, 1310771, 1310772, 1310779, 1310780, 1310781, 1310788, 1310789, 1310790, 1310799, 1311524, 1311525, 1311526, 1311527, 1311528, 1311529, 1311530, 1311531, 1311532, 1311533, 1311534, 1311535, 1311536, 1311537, 1311538, 1311539, 1311541, 1311542   Model Number 110706: Lot numbers: 1310207, 1310208, 1310209, 1310210, 1310211, 1310212, 1310213, 1310214, 1310215, 1310216, 1310228, 1310231, 1310232, 1310234, 1310235, 1310238, 1310239, 1310247, 1310249, 1310250, 1310256, 1310257, 1310258, 1310259, 1310260, 1311270, 1311271, 1311272, 1311273, 1311274, 1311279, 1311280, 1311281, 1311282, 1311283, 1311284, 1311291, 1311296, 1311297, 1311314, 1311315, 1311316, 1311317, 1311318,   Model Number 110715: Lot numbers: 1310217, 1310218, 1310219, 1310221, 1310222, 1310229, 1310230, 1310237, 1310240, 1310241, 1310242, 1310251, 1310252, 1311267, 1311268, 1311269, 1311298, 1311301, 1311302, 1311303, 1311304, 1311321, 1311322, 1311323, 1311324  Model Number 110716: Lot numbers: 1310202, 1310203, 1310204, 1310223, 1310224, 1310225, 1310227, 1310243, 1310244, 1310245, 1310246, 1310261, 1311263, 1311264, 1311265, 1311266, 1311277, 1311278, 1311305, 1311306, 1311307, 1311308, 1311309, 1311310, 1311311, 1311312, 1311313, 1311325   Model Number 110717: Lot numbers: 1310504, 1310505, 1310506, 1310507, 1310508, 1310509, 1310510, 1310514, 1310515, 1310516, 1310517, 1310773, 1310774, 1310775, 1310776, 1310783, 1310784, 1310785, 1310791, 1310792, 1310794, 1310795, 1310796, 1311540, 1311543, 1311544, 1311545   Model Number 110718: Lot numbers: 1310511, 1310512, 1310513, 1310777, 1310778, 1310786, 1310787, 1310797, 1310798  Model Number 110719: Lot numbers: 1310236, 1310237, 1310248, 1311285, 1311286, 1311287, 1311288, 1311289, 1311290, 1311292, 1311293, 1311294, 1311295, 1311299, 1311300  Model Number 110720: Lot numbers: 1310205, 1310206, 1310226, 1310253, 1310254, 1310255, 1311319, 1311320

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution-US (nationwide) and the countries of Canada, Austria, AUSTRALIA, SWITZERLAND, COTE D'IVOIRE, CYPRUS, CZECH REPUBLIC, GERMANY, DENMARK, FINLAND, FRANCE, UNITED KINGDOM, GEORGIA, HONG KONG, CROATIA, HUNGARY, IRELAND, INDIA, ICELAND, JAPAN, KENYA, MACEDONIA, MALTA, NETHERLANDS, NORWAY, NEPAL, NEW ZEALAND, POLAND, ROMANIA, RUSSIA, SWEDEN, SLOVENIA, UNITED REPUBLIC OF TANZANIA, and SOUTH AFRICA.

HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials. || Affected lots identified initially were 110705, 110706, 110715, 110716, 110717, 110718, 110719, and 110720. Subsequent investigation also identified as affected lots 1310227, 1310252, and 1310257. || HemoCue¿ Glucose 201 Microcuvettes, The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201Analyzer and the HemoCue Glucose 201 DM Analyzer (hereafter referred to as the HemoCue Glucose 201 Analyzer). HemoCue Glucose 201 Microcuvettes are available in individual packages or in vials.

Lot R0375N009, Model #393-090, S/N 393-090R0027N001 - 393-090R0379N010

Clinical Chemistry and Clinical Toxicology Devices

2

No

Worldwide Distribution - USA including AL, AZ, CA, CO, CT, DC, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI & WV and Internationally to Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Hungary, Italy, Japan, Netherlands, Norway, Poland, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey & United Kingdom.

ABL90 FLEX Analyzer Radiometer Medical ApS, ¿kandevej 21 || Br¿nsh¿j, Denmark || A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood.

Part Number: 942-066 R1741 to R1869

Clinical Chemistry and Clinical Toxicology Devices

1

No

Nationwide Distribution, including the states of: AK, AL, AR, AZ, BM, CA, CO, CT, DC, FL, GA, IA, 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, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV.

Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood.

Verions 2.4X, 2.5X and 2.6X

Clinical Chemistry and Clinical Toxicology Devices

1

No

Worldwide Distribution - US (nationwide) in the states of AZ, CA, MO, MS, TX and UT. and the countries of: Austrialia, Austria, France, UK, Italy, Japan, Spain, India, and the Netherlands.

RADIANCE v. 2.4X, 2.5X and 2.6X || Product Usage: RADIANCE is a data processing application for clinical use intended to monitor, collect, store, retrieve and process laboratory data. RADIANCE is also intended to control clinical analyzers providing laboratory data.