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.
Read the official notice →- Date
- 2025-06-11
- Country
- United States
- Brand
- Beckman Coulter
- Product
- DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20
- Classification
- Class II
- Units
- Worldwide Distribution: US (Nationwide) and OUS (Global) to countries of:…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2025-07-02
USBeckman Coulter Inc. recalls REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412;…
Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left empty, REMISOL Advance may…
FDA · DeviceBeckman Coulter Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AL,AR,…Official notice →- US
Beckman 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 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…
- 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 →
Other drugs & medical recalls in the United States
- 2025-06-18
- US
- US
AvKARE recalls Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
- US
Alembic Pharmaceuticals Limited recalls Celecoxib Capsules, 200 mg, 500-count bottle, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division),…
Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
- 2025-06-11
- US
Olympus Corporation of the Americas recalls Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
Recent post-market surveillance data suggests a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed,…
FDA · DeviceOlympus Corporation of the AmericasWorldwide Distribution: US (Nationwide) and OUS (International) countries to:…Official notice → - US
Healthmark Industries Co., Inc. recalls ChannelCheck Convenience Pack, Model Numbers UCC-222CP and UCC-222-ESP (Sample)
During endoscope surveillance monitoring, a user facility identified contamination from duodenoscope samples that were linked to the Pre-filled Water Syringes as part of their investigation. Healthmark Industries…
FDA · DeviceHealthmark Industries Co., Inc.US Nationwide and Internationally to countries of: Canada, Malaysia.Official notice → - US
Beckman Coulter Mishima K.K. recalls Sample probe sucks a sample dispensed into a tube or cup and discharges the appropriate amount into a cuvette. Lot 178713114 -…
Sample probes with defective probe tips, when used with clinical chemistry analyzers, may lead to a lower concentration being dispensed, which may not be detectable by QC checks, which could lead to the reporting of…
FDA · DeviceBeckman Coulter Mishima K.K.Worldwide Distribution: US (nationwide) including states of: CA, PA, VA, TX,…Official notice →