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…
Read the official notice →- Date
- 2021-10-20
- Country
- United States
- Brand
- Inpeco
- Product
- FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)
- Classification
- Class II
- Units
- Domestic distribution nationwide . Foreign distribution worldwide.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- US
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…
- 2023-12-27
- 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 →
Other drugs & medical recalls in the United States
- 2021-10-20
- US
K2M, Inc recalls Chesapeake Anterior Lumbar (AL) Removal Tool; Cat. no. 2008-90068
Units may arrive with missing pins and/or in a state in disassembly. Pins dislodging from the instrument during a procedure may enter the surgical cavity, requiring intraoperative removal or revision surgery.
FDA · DeviceK2M, IncDomestic distribution to CO, IL, LA, MA, MS, OK, PA, TN, and TX. Foreign…Official notice → - US
Smiths Medical ASD Inc. recalls smiths medical medex CBSS-5ML, Triple set, (172/15cm), Model Number DPSHC0092
Reported pressure shifts and incorrect pressure readings in LogiCal Closed Blood Sampling System sets.
FDA · DeviceSmiths Medical ASD Inc.Austria, France, Germany, Great Britain, and Saudi ArabiaOfficial notice → - US
Red Medical Supplies recalls EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021,FDA published a Letter to Health Care Providers to further address this issue:…
FDA · DeviceRed Medical SuppliesFirm sold product through Amazon.com. Domestic distribution nationwide.Official notice → - US
Medtronic Sofamor Danek USA Inc recalls Endoskeleton" TCS Interbody System with Titan nanoLOCK" Surface Technology, NanoLock, 6 Deg, Interbody, Medium, 10mm
Engraving on implants may not match what is listed on the pouch labels.
FDA · DeviceMedtronic Sofamor Danek USA IncDistribution in US: CA, MN, MO, NC, NV, NY, OH, OK, OR, PA, SC, SD, WA, WVOfficial notice → - US
BioMerieux SA recalls MYLA Versions: 4.7, 4.7.1, 4.8, 4.8.1 and 4.8.2, part of the VIRTUO System
Under certain conditions, there is a risk for a false negative result.
FDA · DeviceBioMerieux SAWorldwide distribution - US Nationwide distribution and the countries of…Official notice → - US
Roche Molecular Systems, Inc. recalls cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog Number :07248563190
False Mutation Detected results for the exon 20 insertion (Ex20Ins) mutation when using the cobas EGFR Mutation Test v2, may lead to inappropriate treatment
FDA · DeviceRoche Molecular Systems, Inc.Worldwide distribution - US Nationwide distribution and the countries of…Official notice →