Siemens Healthcare Diagnostics, Inc recalls Atellica IM 1600 Analyzer, SMN 11066000
Ancillary reagent packs used on Atellica IM 1300 and Atellica IM 1600 analyzers may overflow when pierced while on an analyzer located at an altitude of greater than 350m (1148ft) above sea level. As a result,…
Read the official notice →- Date
- 2021-10-27
- Country
- United States
- Brand
- Siemens Healthcare Diagnostics
- Product
- Atellica IM 1600 Analyzer, SMN 11066000
- Classification
- Class II
- Units
- Domestic distribution to AZ CA CO GA ID KS MO MT NC NE NM NV OH OK OR PA TN TX…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-01-05
US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH ¿2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determination of…
¿2 Microglobulin (B2M) Reagent Lot 211446 Bias with Quality Control and Patient Sample Results. Positive bias on patient samples of up to +20.9% at a B2M concentration of approximately 1.5 mg/L and a negative bias on…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution in the states of CA, CO,…Official notice →- 2021-12-08
US
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting,…
Incorrect Default Hemolysis, Icterus or Lipemia (HIL) Index for Five Dimension Vista Assays
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution and the countries of DE,…Official notice →- 2021-11-10
US
Siemens Healthcare Diagnostics, Inc recalls ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
Data provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the intended use.
FDA · DeviceSiemens Healthcare Diagnostics, IncUS Nationwide distribution in the states of AK, CA, CO, DC, GA, IL, ME, NC,…Official notice →US
Siemens Healthcare Diagnostics, Inc. recalls Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmware (FW) CENa_3-1-0-1…
The Aptio Automation Firmware for the ADVIA Centaur XP/XPT Interface Module may lead, in some cases, to an incorrect association of test results to sample ID. Incorrect association of test results could impact clinical…
- 2021-11-03
US
Siemens Healthcare Diagnostics, Inc. recalls Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
The firm has confirmed the potential for ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution.Official notice →US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
The firm has confirmed the potential for Atellica CH Urinary/Cerebrospinal Fluid Protein reagent carryover impacting Enzymatic Hemoglobin A1c (A1c_E and A1c_EM) results. Falsely depressed Enzymatic Hemoglobin A1c…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution.Official notice →
Other drugs & medical recalls in the United States
- 2021-10-27
US
Canon Medical System, USA, INC. recalls Canon PET-CT SCANNER, Cartesion Prime, MODEL PCD-1000A
A software problem has been identified which could result in the diagnostic imaging system not proceeding to the next actual scan even though automatic start of the next scan is specified. This could result in the…
FDA · DeviceCanon Medical System, USA, INC.US Nationwide distribution in the states of NV, AR MN.Official notice →US
GE Healthcare, LLC recalls SIGNA Pioneer nuclear magnetic resonance imaging system
Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
FDA · DeviceGE Healthcare, LLCDistribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH,…Official notice →US
Stradis Medical, LLC dba Stradis Healthcare recalls Foundation Kit
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
FDA · DeviceStradis Medical, LLC dba Stradis HealthcareDistributed nationwide to VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK,…Official notice →US
Philips Ultrasound Inc recalls EPIQ CVxi Diagnostic Ultrasound Systems, Product Code: 795232
Ultrasound system software issue can cause an EchoNavigator error notification, leading to an unresponsive system, necessitating system restart, which could lead to therapy/treatment delay and/or unnecessary…
FDA · DevicePhilips Ultrasound IncUS: MI, AZ, IA, TN, OH, CO, WI, NY, NJ, NC, LA, IL, CA, KY, IN, MD, TX, PA.…Official notice →US
Implant Resource Inc recalls MPR Slotted Mallet, labeling etched onto devices as follows: Medical Products Resource 800.524.5194 www.m-p-r.com MPR-1120-1000…
Potential for mallet head to become separated from mallet handle. There is also significant deformations on striking surface that were not expected
US
Fort Defiance Industries, LLC recalls P2131 Automated Field Steam Sterilizer NSN: 6530-01-641-4641
The rear heater plate and cover assembly that contains the electrical wiring for the heaters does not have sufficient bonding to ground.
FDA · DeviceFort Defiance Industries, LLCDistributed nationwide to PA, MD, TX, NJ, OH, TN, UT, VA and internationally…Official notice →