Recall Atlas
Drugs & medicalClass II

Sysmex America, Inc. recalls Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting,…

Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.

Read the official notice →
Date
2025-02-12
Country
United States
Brand
Sysmex
Product
Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6., Catalog Number BQ716341. Product usage for automated pipetting,…
Classification
Class II
Units
US Nationwide.
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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 Sysmex recalls

  1. 2026-01-28
  2. US
    Drugs & medicalClass II

    Sysmex America, Inc. recalls TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions…

    Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.

    FDA · DeviceSysmex America, Inc.US Nationwide.Official notice →
All 2 Sysmex recalls →

Other drugs & medical recalls in the United States

  1. 2025-02-12
  2. US
    Drugs & medicalClass II

    Medicrea International recalls UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software…

    Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes…

    FDA · DeviceMedicrea InternationalU.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…Official notice →
  3. US
    Drugs & medicalClass II

    Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer, catalog number C11137; in-vitro diagnostic instrument

    A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results.

    FDA · DeviceBeckman Coulter, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →
  4. US
    Drugs & medicalClass II

    US Endodontics, LLC recalls Brasseler ESR Rotary/Reciprocating Endodontic File Device SKU AP120213PK AP120253PK AP120313PK AP125213PK AP125253PK AP125313PK AP135213PK…

    Due to devices being irradiated above the established specification which my result in package integrity issues.

    FDA · DeviceUS Endodontics, LLCWorldwide - US Nationwide distribution in the state of GA and the countries of…Official notice →
  5. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls Access PCT Reagent Pack, Catalog Number C53987, when used on Access 2 and UniCel Dxl Immunoassay Systems

    Identified reagent lots are experiencing a high rate of calibration failures with failure code of "Max Iterate" on Access 2 and UniCel Dxl Immunoassay Systems. Reporting of results may be delayed due to the time…

    FDA · DeviceBeckman Coulter Inc.Worldwide distribution - US Nationwide and the countries of Austria, Bahrain,…Official notice →
  6. US
    Drugs & medicalClass II

    DDS Lab recalls Temporary Titanium Abutments

    Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk…

    FDA · DeviceDDS LabUS Nationwide distribution including in the states of FL, TN, TX, MA, NH, CT,…Official notice →
  7. US
    Drugs & medicalClass II

    Philips North America Llc recalls IntelliVue Patient Monitor MX400. Model Number: 866060

    Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton ventilator is disconnected from the EC10 Module or IntelliBridge I/O board.

    FDA · DevicePhilips North America LlcUS distribution to Florida, North Carolina, and Oregan. International…Official notice →
See all drugs & medical recalls →