Beckman Coulter, Inc. recalls CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and…
Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters,…
Read the official notice →- Date
- 2025-11-05
- Country
- United States
- Brand
- Beckman Coulter
- Product
- CellMek SPS Sample Preparation System, REF: C44603. Software versions 2.2.122.0 and prior, and Instructions for Use (IFU) revisions AD and…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of AL, AR, FL, IL, IN,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Beckman Coulter recalls
- 2025-11-26
USBeckman Coulter Inc. recalls DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro…
Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.
FDA · DeviceBeckman Coulter Inc.Worldwide - U.S. Nationwide distribution in the states of CA, CT, FL, IL, NY,…Official notice →- 2025-11-12
- US
Beckman Coulter Inc. recalls SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706
Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166 may generate false high results. The issue was discovered internally…
FDA · DeviceBeckman Coulter Inc.Worldwide - US Nationwide distribution in the states of AL, AR, CA, FL, GA,…Official notice → - US
Beckman Coulter, Inc. recalls Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading…
- 2025-10-29
- US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering…
- 2025-10-15
- US
Beckman Coulter Inc. recalls SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use, Rx Only.
Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.
FDA · DeviceBeckman Coulter Inc.US: AL KY LA MA MD MS NC NE NJ NY OK PA TX WA WV OUS: Canada Mexico SingaporeOfficial notice → - 2025-10-08
- US
Beckman Coulter Inc. recalls DxC 500 AU Module w/ISE, DxC 500i, With ISE, REF: C63522 and DxC 500 AU Module, DxC 500i, Without ISE, REF: C6352; part of the DxC 500i…
On a clinical analyzer, when ordering a Clinical Chemistry (CC) combination test simultaneously with an Immunoassay (IA) test, if the IA test is processed between the CC tests, CC sample status will remain In Progress…
FDA · DeviceBeckman Coulter Inc.Internationally distribution to the countries of Poland, India, Dominican…Official notice →
Other drugs & medical recalls in the United States
- 2025-11-05
- US
Microgenics Corporation recalls Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303,…
The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays.
FDA · DeviceMicrogenics CorporationWorldwide - US Nationwide distribution in the states of AL, OK, NH, NY, WI,…Official notice → - US
Cepheid recalls Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit; 10 test kit: A collection of…
As a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type.
FDA · DeviceCepheidU.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA,…Official notice → - US
Trividia Health, Inc. recalls Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Model/Catalog Number: RE4011-01.
Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that can result in misreading glucose values, potentially leading to inappropriate treatment decisions for diabetes management.
FDA · DeviceTrividia Health, Inc.US Nationwide distribution in the states of NY, VA, FL, OH, CA, KY, NC.Official notice → - US
MicroSurgical Technology Inc recalls MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation
FDA · DeviceMicroSurgical Technology IncUS Nationwide distribution in the state of GA.Official notice → - US
Medistim Asa recalls Brand Name: Medistim MiraQ System Product Name: Medistim MiraQ System Model/Catalog Number: MQC04001, MQC14001, MQU14011, MQV12011…
Printer Support Module (PSM) may be subject to insufficient soldering, which may cause loosening of the wires and system to shut down. Affected devices need to have their Printer Support Modules replaced.
FDA · DeviceMedistim AsaDomestic distribution to CO, MI, MN, TN, TX. International distribution to…Official notice → - US
Vantive US Healthcare LLC recalls Sharesource Connectivity Platform for Use with Homechoice Claria Product Code 5CGM01 software versions 7.13.3 (China), 8.13.2 (APAC and…
Vantive has identified a software defect within the Sharesource Claria software, which may cause a patient s updated prescription program settings to not be properly saved on the actual cycler that the patient is using…
FDA · DeviceVantive US Healthcare LLCWorldwide distribution - US Nationwide and the countries of Australia, Hong…Official notice →