|
|
| Device |
analyzer, chemistry (photometric, discrete), for clinical use |
| Regulation Description |
Discrete photometric chemistry analyzer for clinical use. |
| Product Code | JJE |
| Regulation Number |
862.2160
|
|---|
| Device Class |
1
|
| Recalls |
| Manufacturer |
Recall Class |
Date Posted |
| 1 |
Abbott Gmbh & Co. KG |
II |
Jul-24-2020 |
| 2 |
Abbott Gmbh & Co. KG |
II |
Jun-18-2020 |
| 3 |
Abbott Gmbh & Co. KG |
II |
Mar-26-2020 |
| 4 |
Abbott Laboratories |
II |
Jan-09-2024 |
| 5 |
Abbott Laboratories |
II |
Dec-22-2023 |
| 6 |
Abbott Laboratories |
II |
Nov-19-2021 |
| 7 |
Abbott Laboratories |
II |
Sep-14-2021 |
| 8 |
Abbott Laboratories, Inc |
II |
Apr-06-2020 |
| 9 |
BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO., LTD. |
II |
Feb-25-2025 |
| 10 |
Beckman Coulter Biomedical GmbH |
II |
Jul-14-2023 |
| 11 |
Beckman Coulter Biomedical GmbH |
II |
Sep-18-2020 |
| 12 |
Beckman Coulter Inc. |
II |
May-15-2025 |
| 13 |
Beckman Coulter Inc. |
II |
Apr-25-2025 |
| 14 |
Beckman Coulter Inc. |
II |
Apr-03-2025 |
| 15 |
Beckman Coulter Inc. |
II |
Sep-30-2021 |
| 16 |
Beckman Coulter Inc. |
II |
Apr-17-2020 |
| 17 |
Beckman Coulter Mishima K.K. |
II |
Jun-04-2025 |
| 18 |
Beckman Coulter Mishima K.K. |
II |
Aug-21-2024 |
| 19 |
Beckman Coulter Mishima K.K. |
II |
Jul-31-2024 |
| 20 |
Beckman Coulter, Inc. |
II |
Nov-04-2025 |
| 21 |
Beckman Coulter, Inc. |
II |
Aug-05-2025 |
| 22 |
Beckman Coulter, Inc. |
II |
Jun-20-2025 |
| 23 |
Beckman Coulter, Inc. |
II |
Apr-24-2025 |
| 24 |
Beckman Coulter, Inc. |
II |
Apr-04-2025 |
| 25 |
Beckman Coulter, Inc. |
II |
Mar-17-2025 |
| 26 |
Beckman Coulter, Inc. |
II |
Mar-17-2025 |
| 27 |
Beckman Coulter, Inc. |
II |
Mar-17-2025 |
| 28 |
Beckman Coulter, Inc. |
II |
Mar-12-2025 |
| 29 |
Beckman Coulter, Inc. |
II |
Feb-06-2025 |
| 30 |
Beckman Coulter, Inc. |
II |
Oct-07-2024 |
| 31 |
Beckman Coulter, Inc. |
II |
Sep-19-2024 |
| 32 |
Beckman Coulter, Inc. |
II |
Aug-30-2024 |
| 33 |
Beckman Coulter, Inc. |
II |
Aug-27-2024 |
| 34 |
Beckman Coulter, Inc. |
II |
Aug-09-2024 |
| 35 |
Beckman Coulter, Inc. |
II |
Aug-09-2024 |
| 36 |
Beckman Coulter, Inc. |
II |
Jul-23-2024 |
| 37 |
Beckman Coulter, Inc. |
II |
Jul-03-2024 |
| 38 |
Beckman Coulter, Inc. |
II |
Jun-28-2024 |
| 39 |
Beckman Coulter, Inc. |
II |
Feb-05-2024 |
| 40 |
Beckman Coulter, Inc. |
II |
Oct-12-2023 |
| 41 |
Beckman Coulter, Inc. |
II |
Jul-26-2023 |
| 42 |
Beckman Coulter, Inc. |
II |
Mar-15-2023 |
| 43 |
Biomerieux Inc |
II |
Mar-02-2020 |
| 44 |
Inpeco S.A. |
II |
May-05-2020 |
| 45 |
Mckesson Medical-Surgical Inc. Corporate Office |
II |
May-27-2025 |
| 46 |
Mckesson Medical-Surgical Inc. Corporate Office |
II |
Aug-26-2022 |
| 47 |
Ortho Clinical Diagnostics |
II |
Aug-24-2020 |
| 48 |
Ortho Clinical Diagnostics |
II |
Jul-01-2020 |
| 49 |
Ortho-Clinical Diagnostics, INc. |
II |
Jan-21-2025 |
| 50 |
Ortho-Clinical Diagnostics, Inc. |
II |
Jun-27-2025 |
| 51 |
Ortho-Clinical Diagnostics, Inc. |
II |
Mar-01-2024 |
| 52 |
Ortho-Clinical Diagnostics, Inc. |
II |
Mar-01-2024 |
| 53 |
Ortho-Clinical Diagnostics, Inc. |
II |
Mar-01-2024 |
| 54 |
Ortho-Clinical Diagnostics, Inc. |
II |
Dec-13-2023 |
| 55 |
Ortho-Clinical Diagnostics, Inc. |
II |
Oct-02-2023 |
| 56 |
Ortho-Clinical Diagnostics, Inc. |
II |
May-04-2023 |
| 57 |
Ortho-Clinical Diagnostics, Inc. |
II |
Sep-02-2022 |
| 58 |
Ortho-Clinical Diagnostics, Inc. |
II |
Jan-07-2021 |
| 59 |
Randox Laboratories Ltd. |
III |
May-09-2024 |
| 60 |
Randox Laboratories, Limited |
II |
Feb-24-2020 |
| 61 |
Roche Diagnostics Operations, Inc. |
II |
Aug-11-2022 |
| 62 |
Roche Diagnostics Operations, Inc. |
II |
May-24-2021 |
| 63 |
Roche Diagnostics Operations, Inc. |
II |
Dec-30-2020 |
| 64 |
Roche Diagnostics Operations, Inc. |
II |
Dec-29-2020 |
| 65 |
Siemens Healthcare Diagnostics Inc. |
II |
Jun-29-2020 |
| 66 |
Siemens Healthcare Diagnostics, Inc |
II |
Oct-16-2021 |
| 67 |
Siemens Healthcare Diagnostics, Inc. |
II |
Jun-25-2025 |
| 68 |
Siemens Healthcare Diagnostics, Inc. |
II |
Dec-04-2024 |
| 69 |
Siemens Healthcare Diagnostics, Inc. |
II |
Nov-20-2024 |
| 70 |
Siemens Healthcare Diagnostics, Inc. |
II |
Jul-05-2023 |
| 71 |
Siemens Healthcare Diagnostics, Inc. |
II |
Dec-02-2021 |
| 72 |
Siemens Healthcare Diagnostics, Inc. |
II |
Jan-14-2021 |
| 73 |
Siemens Healthcare Diagnostics, Inc. |
II |
Jun-19-2020 |
| 74 |
The Binding Site Group, Ltd. |
II |
May-21-2020 |
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