Siemens Healthcare Diagnostics Inc recalls RAPIDPOINT 500 Blood Gas System
There are potential drug interferences from Perhexiline Maleate or Atomoxetine Hydrochloride that may cause falsely elevated sodium results reported on the RAPIDPoint 500 and RAPIDPoint 500e Blood Gas Systems. The…
Read the official notice →- Date
- 2023-12-06
- Country
- United States
- Brand
- Siemens Healthcare Diagnostics
- Product
- RAPIDPOINT 500 Blood Gas System
- Classification
- Class II
- Units
- Domestic: Nationwide Distribution. Foreign: Albania, Algeria, Angola,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Siemens Healthcare Diagnostics recalls
- 2024-02-14
USSiemens Healthcare Diagnostics, Inc. recalls Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
Potential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution including in the states of AL, AR, AZ,…Official notice →- 2023-12-27
- US
Siemens Healthcare Diagnostics Inc recalls RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to…
RAPIDPoint 500 Systems Measurement Cartridges (with lactate) has the potential to affect the Sodium (Na+) sensor to produce a negative bias that could result in serious injury due to a delayed diagnosis of…
FDA · DeviceSiemens Healthcare Diagnostics IncNationwide with Worldwide Distribution to: Albania Algeria Angola Argentina…Official notice → - US
Siemens Healthcare Diagnostics Inc recalls epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX),…
Siemens Healthcare Diagnostics Inc. has confirmed a potential issue that could occur under certain conditions, a software problem is causing erroneous results to be printed. When the results are run on the epoc NXS…
- 2023-10-11
- US
Siemens Healthcare Diagnostics, Inc. recalls ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7 x 145 tests)
There is a potential for a positive bias on Quality Control (QC) and patient sample results when using some IRON_2 reagent wedge pairs. When the issue occurs, the observed bias will vary wedge to wedge.
- 2023-09-06
- US
Siemens Healthcare Diagnostics Inc recalls epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
There is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range.
FDA · DeviceSiemens Healthcare Diagnostics IncUS distribution to AL, AR, AZ, CA, CO, DC, DE, FL, IA, ID, IL, KS, KY, LA, MI,…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of gamma-glutamyl…
Potential for reagent carryover on the Atellica CH 930 resulting in a positive bias that could impact quality control (QC), patient samples, and calibrator results with from Atellica¿CH Total Bilirubin_2 (TBil_2),…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.US Nationwide - Worldwide Distribution Foreign: Taiwan Uruguay VietnamOfficial notice →
Other drugs & medical recalls in the United States
- 2023-12-13
- US
Padagis US LLC recalls Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories (India) Pvt.…
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
- US
SUGARMDS LLC recalls Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC 1 95893…
MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide
- US
- 2023-12-06
- US
Medtronic Inc. recalls ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor
It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to…
FDA · DeviceMedtronic Inc.US and Australia, Austria, Belgium, Brunei Darussalam, Canada, Czech Republic,…Official notice → - US
Aizu Olympus Co., Ltd. recalls PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE
Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or…
FDA · DeviceAizu Olympus Co., Ltd.Domestic distribution to FL, KY, MA, NJ, NY, and PAOfficial notice → - US
Edwards Lifesciences, LLC recalls Acumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use in intravascular pressure monitoring.
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
FDA · DeviceEdwards Lifesciences, LLCUS: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO…Official notice →