Inpeco S.A. recalls Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate…
Firmware of the Interface Module with Roche Cobas 8000 and Cobas PRO (CO8 IM) may lead to a delayed sample tube processing.
Read the official notice →- Date
- 2023-12-27
- Country
- United States
- Brand
- Inpeco
- Product
- Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the state of MA and the countries of…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Inpeco recalls
- 2025-12-03
USInpeco S.A. recalls FlexLab (FLX); Version: FLX-217-40;
The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results, this error occurs if the operators open the printer…
FDA · DeviceInpeco S.A.US Domestic: MI. OUS International: Australia, Finland, France, Germany,…Official notice →- 2025-10-15
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Inpeco S.A. recalls FlexLab X (FXX) System. Potassium Test System. in vitro diagnostic
The FlexLab X System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the…
- US
Inpeco S.A. recalls FlexLab (FLX) System. Potassium Test System. in vitro diagnostic
The FlexLab System Sample Integrity Module (SIM) includes function that determines the hemolysis, icterus, and lipemia (HIL) in blood samples. This function has not been evaluated for safety and effectiveness by the…
- 2023-05-10
- US
Inpeco S.A. recalls Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of the same product: FlexLab (FLX), Accelerator a3600 (ACP),…
Firmware versions have the potential to mis-associate sample IDs leading to incorrect results or delayed sodium, potassium, and chloride patient results. Falsely increased or decreased electrolytes can lead to either…
FDA · DeviceInpeco S.A.Worldwide distribution - US Nationwide and the countries of ARGENTINA,…Official notice → - 2021-10-20
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Inpeco S.A. recalls FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient…
FDA · DeviceInpeco S.A.Domestic distribution nationwide . Foreign distribution worldwide.Official notice →
Other drugs & medical recalls in the United States
- 2023-12-27
- US
Physio-Control, Inc. recalls AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
AC Power Adapter (ACPA) may not charge the monitor/defibrillator batteries and may not allow the monitor/defibrillator to power on while plugged into the ACPA.
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CardioQuip, LLC recalls CardioQuip Modular Cooler-Heater, Model: MCH-1000(m), Power: 115V-60Hz, 16A
There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.
FDA · DeviceCardioQuip, LLCUS: California, Texas, Pennsylvania, Washington, Ohio, Nebraska OUS: NoneOfficial notice → - US
Vero Biotech, LLC recalls VERO BIOTECH GENOSYL DS (Delivery System) Generation 3 Cassette, Model Number 602722-01; generates and delivers nitric oxide (NO) for…
Cassette did not meet an 1n-process flow criterion.
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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7…
Ceiling mounted L-arm contains a rotation cover that may potentially be susceptible to falling if a collision between the L-arm and other hospital equipment (i.e., an operating light) were to occur result in injury or…
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Worldwide - US Nationwide and the countries of Albania, Algeria, Argentina,…Official notice → - US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of…
FDA · DeviceFresenius Kabi USA, LLCUS distribution to states of: CA, CO, NJ, UT, and WI.Official notice → - US
ResMed Ltd. recalls AirTouch F20 Full Face Mask and User Guide
Masks non-invasive interface for channeling airflow to patients have magnets that have potential magnetic interference with active medical implants that interact with magnets, and metallic implants/objects containing…
FDA · DeviceResMed Ltd.US nationwide distribution including Puerto Rico, Guam, and Virgin Islands.…Official notice →