Beckman Coulter, Inc. recalls Access Testosterone assay, Catalog Number 33560
Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result…
Read the official notice →- Date
- 2025-06-11
- Country
- United States
- Brand
- Beckman Coulter
- Product
- Access Testosterone assay, Catalog Number 33560
- Classification
- Class II
- Units
- US State: FL. UAE, Vietnam
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
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- 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
- 2025-07-02
USBeckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer C11137
Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the states of AR, CA, FL, GA, HI,…Official notice →- 2025-06-18
- US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20
A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the…
FDA · DeviceBeckman Coulter, Inc.Worldwide distribution: US (Nationwide) and OUS Global (Foreign) to countries…Official notice → - 2025-06-11
- US
Beckman Coulter, Inc. recalls DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
FDA · DeviceBeckman Coulter, Inc.Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of:…Official notice → - 2025-05-21
- US
Beckman Coulter Inc. recalls DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter…
Beckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes the analyzer to not run a requested calibration order in the following scenario: when a reagent blank or…
FDA · DeviceBeckman Coulter Inc.U.S: AL, CA, GA, ID, IN, LA, MA, MI, MN, MT, NC, NV, PA, PR, TN , TX, and WI…Official notice → - 2025-05-07
- US
Beckman Coulter Inc. recalls DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions:…
The reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed results.
FDA · DeviceBeckman Coulter Inc.Worldwide - U.S. Nationwide distribution including in the states of AL, CA,…Official notice → - 2025-04-30
- US
Beckman Coulter, Inc. recalls Beckman Coulter DxI 9000 Access Immunoassay Analyzer
When DxI 9000 Access Immunoassay Analyzer is connected to a host system (laboratory information system (LIS) or middleware) and has accumulated canceled QC test results that were not sent by LIS, the analyzer may lose…
Other drugs & medical recalls in the United States
- 2025-06-11
- US
Dexcom, Inc. recalls Dexcom G7 iOS Application, Ref: SW12300 used in conjunction with the Dexcom G7 Continuous Glucose Monitoring (CGM) system
A bug in the 2.7.0 version of the G7 iOS App can cause the app to enter a state where it stops updating the estimated glucose value (EGV) and continues to show this stale EGV. If the user is unaware that the EGVs are…
FDA · DeviceDexcom, Inc.Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of:…Official notice → - US
VIRTUAL INCISION CORPORATION recalls MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version…
The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have the potential to exhibit interrupted motion on the display screen, caused by a software latency between the movement of the…
- US
Luminex Corporation recalls VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System;…
It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
FDA · DeviceLuminex CorporationUS Nationwide distribution in the states of AL, CA, MN, TX, AZ, NJ, WA, SC,…Official notice → - US
Silex Medical, LLC recalls Signature Laparoscopic Instruments, Bullet Tip Grasper with Rotating Shaft and Monopolar Electrosurgical Footswitch Connector. Model/REF…
Insulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft closer to the rotator wheel.
FDA · DeviceSilex Medical, LLCUS Nationwide distribution in the states of Florida, North Dakota, Illinois,…Official notice → - US
Civco Medical Instruments Co. Inc. recalls BX2 Needle Guide, Part Number 644-094, tool for performing needle-guided (or catheter) procedures with the use of diagnostic…
During the attachment of the needle guide to the covered probe, the tight tolerance and fit of the needle guide can cause a pinhole breach in the transducer cover when latching the guide in place.
FDA · DeviceCivco Medical Instruments Co. Inc.OUS Distribution to countries of: Japan, Taiwan, France, Georgia, Germany and…Official notice → - US
Foundation Medicine, Inc. recalls FoundationOne Companion Diagnostic (F1CDx)
An incorrect negative claim was identified on the claims page; the device variant information was displayed correctly in the tumor profiling section of the FDA-approved test report.
FDA · DeviceFoundation Medicine, Inc.US Nationwide distribution in the state of WI.Official notice →