Home / Recalls / Radiometer Medical ApS / Z-1684-2020

Z-1684-2020 Class II Terminated

Recalled by Radiometer Medical ApS — Bronshoj, N/A

FDA device recall Z-1684-2020 was initiated by Radiometer Medical ApS on March 10, 2020 and is designated Class II. Reason for recall: Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ID or accession number. The issue is related to barcode types not using a check digit. This could resul… The recall status is terminated (terminated October 31, 2022). Affected quantity: 3,656 units.

Recall Details

Product Type
Devices
Report Date
April 15, 2020
Initiation Date
March 10, 2020
Termination Date
October 31, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
3,656 units

Product Description

ABL800 FLEX, model number/UDI 393-800/0570 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.0693938004 and 393-801/05700693938011 - Product Usage:

Reason for Recall

Analyzer's barcode reader misinterprets the contents of barcode label used for entering patient ID or accession number. The issue is related to barcode types not using a check digit. This could result in patient mixup or loss of sample resulting in delayed medical treatment

Distribution Pattern

Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, BM, CA, CO, CT, DC, DE, 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, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and countries of Canada, China, Czech Republic, Denmark, Germany, Spain, France, Hungary, United Kingdom, Australia, Poland, South Africa, Singapore, Switzerland, Turkey, Norway, Austria, Italy, Sweden, Finland, Croatia, Russia, Norway.

Code Information

Software versions below 6.19

Other recalls by Radiometer Medical ApS

  • Z-1659-2025 Class II — Radiometer ABL90 Series - Radiometer ABL90 FLEX Model Number 393-090 Radiomet (March 21, 2025)
  • Z-2426-2024 Class II — ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are (May 31, 2024)
  • Z-1394-2023 Class II — AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQ (March 8, 2023)
  • Z-1321-2022 Class II — ABL800 Flex Analyzer Model Numbers 393-800 and 393-801 (May 18, 2022)
  • Z-1115-2022 Class II — Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrol (April 8, 2022)
  • Z-1856-2021 Class II — Radiometer ABL90 FLEX Analyzer with E3800 PC units. The E3800 CPU is also use (April 14, 2021)
  • Z-1858-2021 Class II — E3800 PC Units (spare parts) (April 14, 2021)
  • Z-1857-2021 Class II — Radiometer ABL90 FLEX PLUS Analyzer with E3800 PC units. The E3800 CPU is als (April 14, 2021)
  • Z-1683-2021 Class II — PIC070 Arterial Blood Sampler PICO70 - Product Usage: Preheparinized, electrolyt (March 26, 2021)
  • Z-2494-2020 Class II — Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393- (May 26, 2020)

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