Beckman Coulter Mishima K.K. recalls DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in…
There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved for calibration, after a calibration test has been placed and completed, the same rack may be used to place both a patient…
Read the official notice →- Date
- 2024-08-07
- Country
- United States
- Brand
- Beckman Coulter Mishima K.K
- Product
- DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination…
- Classification
- Class II
- Units
- Worldwide - U.S. Nationwide distribution in the states of AL, CA, GA, HI, IL,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Mishima K.K recalls
- 2026-10-07
US
Beckman Coulter Mishima K.K. recalls Systems/units containing affected software/SQL BECKMAN COULTER CHEMISTRY ANALYZER AU480 REF / UDI-DI code: B96692 / 14987666542965…
Certain AU480 chemistry analyzers, with Windows 10 IoT Enterprise 2021 LTSC PCs, may output the message System Stopped By Fatal Error: DBConnectionError AlarmDB when launching the instrument software, using PC…
FDA · DeviceBeckman Coulter Mishima K.K.Worldwide - U.S. Nationwide distribution in the states of AR, CA, DE, FL, GA,…Official notice →- 2026-03-18
US
Beckman Coulter Mishima K.K. recalls CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases…
FDA · DeviceBeckman Coulter Mishima K.K.US Nationwide distribution including in the states of NE, WA, PA, CA, AZ, NC,…Official notice →- 2025-06-11
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 →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 -…
A manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent the proper formation of the "air layer" required for normal dispensing.…
FDA · DeviceBeckman Coulter Mishima K.K.Worldwide Distribution: US (nationwide) including states of: CA, PA, VA, TX,…Official notice →- 2024-08-28
US
Beckman Coulter Mishima K.K. recalls DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in…
Due to a software issues, after the instrument processes 250 racks cumulatively, any subsequent racks with samples requiring rerun/reflex will be held in the Sample Handler's Buffer area and and error code "9000" will…
FDA · DeviceBeckman Coulter Mishima K.K.Worldwide - U.S. Nationwide distribution in the states of AL, CA, GA, HI, IL,…Official notice →
Other drugs & medical recalls in the United States
- 2024-08-07
US
Becton Dickinson Infusion Therapy Systems, Inc. recalls BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, REF: 382533, 20 GA x 1.00 in (1.1x25…
Catheters may contain a hole in the catheter tubing, which could result in leakage during the insertion process.
US
Medivance Inc. recalls Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/6000-00-00; Arctic Sun STAT Loaner, NA/6000-00-00L; Arctic Sun…
If temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden patient temperature changes/interruption in water flow/blockage of air…
FDA · DeviceMedivance Inc.Worldwide - US Nationwide distribution including in the states of IN, OK, MO,…Official notice →US
BioFire Diagnostics, LLC recalls BIOFIRE Blood Culture Identification 2 (BCID2) Panel, REF: RFIT-ASY-0147, for FILMARRAY Systems, when used in conjunction with Culture…
If blood culture identification panel is used in conjunction with specific lots of culture media bottles, then false positive Serratia marcescens results may occur, due to an increased level of non-viable organism from…
FDA · DeviceBioFire Diagnostics, LLCWorldwide - US Nationwide distribution including in the states of FL, IL, KY,…Official notice →US
Angiodynamics, Inc. recalls SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702
Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)
US
Boston Scientific Corporation recalls Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner Package UPN: M0068318260. Capio SLIM Suture…
Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention.
FDA · DeviceBoston Scientific CorporationDomestic: Nationwide Distribution. International: PendingOfficial notice →US
Zimmer, Inc. recalls CPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip Arthroplasty; Item Numbers 00811400000 00811400010…
Affected product has an increased risk of postoperative perisprosthetic femoral fracture (PFF). The IFU is being updated to reflect the risk of PFF.