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U.S. Department of Health and Human Services

Medical Device Recalls
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therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA) 2 04/19/2022 FEI # 3003572099
Qiagen Sciences LLC
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD) 2 04/19/2022 FEI # 3003572099
Qiagen Sciences LLC
therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711 2 08/29/2022 FEI # 3003572099
Qiagen Sciences LLC
therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121 2 06/05/2020 FEI # 3003572099
Qiagen Sciences LLC
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ ... 2 09/26/2022 FEI # 3007981285
Tandem Diabetes Care Inc
t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ ... 2 09/26/2022 FEI # 3007981285
Tandem Diabetes Care Inc
t:slim X2 insulin pump with Interoperable Technology, Control-IQ+ technology, REF: 1014070, 1014071,... 2 10/23/2025 FEI # 3007981285
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Interoperable Technology (with Tandem t:slim mobile app) 2 09/24/2025 FEI # 3007981285
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Interoperable Technology 1 04/11/2025 FEI # 3007981285
Tandem Diabetes Care, Inc.
t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM, and t:slim X2 Insulin Pump with Basal-IQ Technolog... 2 06/10/2022 FEI # 3007981285
Tandem Diabetes Care Inc

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