Inpeco 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…
Read the official notice →- Date
- 2025-12-03
- Country
- United States
- Brand
- Inpeco
- Product
- FlexLab (FLX); Version: FLX-217-40;
- Classification
- Class II
- Units
- US Domestic: MI. OUS International: Australia, Finland, France, Germany,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-10-15
USInpeco 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…
- 2023-12-27
- US
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.
FDA · DeviceInpeco S.A.Worldwide - US Nationwide distribution in the state of MA and the countries of…Official notice → - 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
- US
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
- 2025-12-03
- US
BioFire Diagnostics, LLC recalls BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)
Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.
FDA · DeviceBioFire Diagnostics, LLCUS:AZ, FL,GA,ID NC, NH, NJ, NY, OR, PA, SC OUS: NoneOfficial notice → - US
Stryker Corporation recalls NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita;…
Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction.
FDA · DeviceStryker CorporationWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US
Noah Medical Corporation recalls Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The Galaxy SystemTM and its…
Due to Users not having access to the Instructions for Use/User Manual due to it being password protected.
FDA · DeviceNoah Medical CorporationUS distribution to states of: NY, MA, WV, WY, TN, OH, NJ, MN, CA, MO, ID, IN,…Official notice → - US
Medtronic MiniMed, Inc. recalls CareLink Clinic, REF: MMT-7350
Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview…
FDA · DeviceMedtronic MiniMed, Inc.Worldwide Distribution: US (nationwide) including states of: TX, NC, MN, CA,…Official notice → - US
Argon Medical Devices, Inc recalls Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is indicated for the…
Due to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural delays and/or risk of venous intimal injuries if excessive force is…
FDA · DeviceArgon Medical Devices, IncU.S. (nationwide) distribution to states of: AL, AR, AZ, CA, CO, CT, DC, FL,…Official notice → - US
Pivotal Health Solutions, Inc. recalls Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table
The heat function may become damaged over time due to patients pressing on the areas with heat function components. Damage to components can lead to overheating which can lead to smoldering and melting of the vinyl…
FDA · DevicePivotal Health Solutions, Inc.Distribution to US nationwide, Canada and Japan.Official notice →