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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 9 of 9 Results
Related Medical Device Recalls
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Z-1361-2019 - ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for the quantitative determination of the IgG class of th... 3 05/16/2019 FEI # 1415939
Abbott Laboratories
Z-1356-2019 - ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (H... 3 05/16/2019 FEI # 1415939
Abbott Laboratories
Z-1358-2019 - ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in hu... 3 05/16/2019 FEI # 1415939
Abbott Laboratories
Z-1357-2019 - ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human... 3 05/16/2019 FEI # 1415939
Abbott Laboratories
Z-1360-2019 - ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic an... 3 05/16/2019 FEI # 1415939
Abbott Laboratories
Z-1359-2019 - ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of test precision and the detection of systematic analyt... 3 05/16/2019 FEI # 1415939
Abbott Laboratories
Z-1355-2019 - ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of sirolimus in human... 3 05/16/2019 FEI # 1415939
Abbott Laboratories
Z-1362-2019 - Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for th... 3 05/16/2019 FEI # 1415939
Abbott Laboratories
Z-1363-2019 - Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for th... 3 05/16/2019 FEI # 1415939
Abbott Laboratories
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