Abbott

• AlinIQ 03R8968 Ref 03R8968

  Class I EUDAMEDFDA UDI Active

• Alinity 04T991A Ref 04T991A

  Class I FDA UDI Active

• Alinity 04T993A Ref 04T993A

  Class I FDA UDI Active

• Alinity 04U001A Ref 04U001A

  Class I FDA UDI Active

• Alinity 09P2625 Ref 09P2625

  Class II EUDAMEDFDA UDI Active

• Alinity 09P2635 Ref 09P2635

  Class II EUDAMEDFDA UDI Active

• Alinity 04W211A Ref 04W211A

  Class I FDA UDI Active

• Alinity 04W021A Ref 04W021A

  Class I FDA UDI Active

• Alinity 06T7901 Ref 06T7901

  Class II FDA UDI Active

• Alinity 06T7910 Ref 06T7910

  Class II FDA UDI Active

• Alinity 06T7921 Ref 06T7921

  Class II FDA UDI Active

• Alinity 08P4321 Ref 08P4321

  Class II EUDAMEDFDA UDI Active

• Alinity 06T7931 Ref 06T7931

  Class II FDA UDI Active

• Alinity 04T851B Ref 04T851B

  Class I FDA UDI Active

• Alinity 04T855B Ref 04T855B

  Class I FDA UDI Active

• Alinity 04T853B Ref 04T853B

  Class I FDA UDI Active

• Alinity 04T857B Ref 04T857B

  Class I FDA UDI Active

• Alinity 06T321A Ref 06T321A

  Class I FDA UDI Active

• Alinity 06T793A Ref 06T793A

  Class I FDA UDI Active

• Alinity 09P261D Ref 09P261D

  Class I FDA UDI Active

• Amplatzer TorqVue LP Delivery System Ref K261825

  Class II FDA 510(k) Active

• Architect 6L23-01 Ref 6L23-01

  Class II FDA UDI Active

• Architect 7D73-22 Ref 7D73-22

  Class II FDA UDI Active

• Architect 02K4524 Ref 02K4524

  Class II EUDAMEDFDA UDI Active

• Alinity 09P5920 Ref 09P5920

  Class II FDA UDI Active

• Alinity 08P6101 Ref 08P6101

  Class II FDA UDI Active

• Alinity 07P8401 Ref 07P8401

  Class II FDA UDI Active

• Alinity 04Z231A Ref 04Z231A

  Class I FDA UDI Active

• Architect 3L79-32 Ref 3L79-32

  Class II FDA UDI Active

• Alinity 08P361A Ref 08P361A

  Class I FDA UDI Active

• Alinity 08P5620 Ref 08P5620

  Class I FDA UDI Active

• Architect 3P24-25 Ref 3P24-25

  Class II FDA UDI Active

• Alinity 07P4540 Ref 07P4540

  Class II FDA UDI Active

• Architect 2K98-03 Ref 2K98-03

  Class I FDA UDI Active

• Architect 06P2237 Ref 06P2237

  Class II FDA UDI Active

• Alinity 04T811A Ref 04T811A

  Class I FDA UDI Active

• FIRMap AR064050 Ref AR064050

  Class II FDA UDI Active

• Architect 08K2529 Ref 08K2529

  Class II FDA UDI Active

• Alinity 08P021A Ref 08P021A

  Class I FDA UDI Active

• Alinity 09P341A Ref 09P341A

  Class I FDA UDI Active

• Architect 6L22-10 Ref 6L22-10

  Class II FDA UDI Active

• Alinity 08P321A Ref 08P321A

  Class I FDA UDI Active

• Alinity 07P921A Ref 07P921A

  Class I FDA UDI Active

• Alinity 07P981A Ref 07P981A

  Class I FDA UDI Active

• Alinity 06P0850 Ref 06P0850

  Not classified FDA UDI Active

• Alinity 07P6801 Ref 07P6801

  Class II EUDAMEDFDA UDI Active

• Alinity 01R141A Ref 01R141A

  Class I FDA UDI Active

• Alinity 06R901A Ref 06R901A

  Class I FDA UDI Active

• Alinity 04U7501 Ref 04U7501

  Class II FDA UDI Active

• Alinity 03R751A Ref 03R751A

  Class I FDA UDI Active

Showing the 10 most recent of 41 recalls.

• 2026

  • 10 Sep 2026 Z-0191-2027 Not yet classified Ongoing Changes to Instructions for Use (IFU) for the device regarding risk of Pulmonary Artery Injury (PAI).via FDA establishment ABBOTT GmbH

• 2025

  • 10 Sep 2025 Z-0109-2026 Class I Ongoing Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.via FDA establishment ABBOTT GmbH
  • 10 Sep 2025 Z-0110-2026 Class I Ongoing Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.via FDA establishment ABBOTT GmbH
  • 10 Sep 2025 Z-0111-2026 Class I Ongoing Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.via FDA establishment ABBOTT GmbH
  • 10 Sep 2025 Z-0112-2026 Class I Ongoing Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.via FDA establishment ABBOTT GmbH
  • 10 Sep 2025 Z-0113-2026 Class I Ongoing Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.via FDA establishment ABBOTT GmbH
  • 17 Mar 2025 Z-1643-2025 Class II Ongoing Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.via FDA establishment ABBOTT GmbH
  • 17 Mar 2025 Z-1644-2025 Class II Ongoing Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead to prolonged procedure, blood loss, or air ingress with potential for air embolism.via FDA establishment ABBOTT GmbH

• 2024

  • 4 Mar 2024 Z-1479-2024 Class II Ongoing Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).via FDA establishment ABBOTT GmbH
  • 4 Mar 2024 Z-1480-2024 Class II Ongoing Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).via FDA establishment ABBOTT GmbH

• ABBOTT GmbH Wiesbaden Hesse · DE FEI 3002809144

Country

US

Website

abbott.com

Email

[email protected]

Phone

+1(650)681-3470

DUNS number

080174723