Siemens Healthcare Diagnostics, Inc. recalls Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
Dimension Magnesium (MG) Flex reagent cartridge lots may exhibit imprecision for Quality Control (QC) and produce Abnormal Reaction flags. The issue is not always detected by QC and erroneous results may be produced in…
Read the official notice →- Date
- 2022-10-05
- Country
- United States
- Brand
- Siemens Healthcare Diagnostics
- Product
- Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):10444963/DF57
- Classification
- Class II
- Units
- Nationwided Foreign: Afghanistan¿¿¿¿ Albania¿¿¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-10-26
USSIEMENS HEALTHCARE DIAGNOSTICS INC recalls N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
N Antiserum to Human IgG are not meeting the current High-Dose Hook Effect expectation of up to 648 mg/L for IgGU (urine) and up to 2290 mg/L for IgGC (CSF).
- US
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Material Number (SMN):…
Dimension Vista¿ High Density Lipoprotein Cholesterol (HDLC) Potential for Erroneous Result. If an HDLC QC or patient result is obtained without an Abnormal Reaction [E145]: flag, a falsely depressed or elevated result…
- 2022-10-05
- US
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Number (SMN): 10876421 US;…
An average negative bias of -23% with IMMULITE 2000/IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) when compared to other in-date kit lots, there is a potential for erroneously depressed patient results.…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide Distribution: US (nationwide) to states of: FL IN MA MI NH NJ NY OH…Official notice → - 2022-09-07
- US
Siemens Healthcare Diagnostics, Inc. recalls Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3.…
Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Austria,…Official notice → - 2022-08-10
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron in human serum and…
Falsely Elevated Atellica CH Microalbumin_2 (¿ALB_2) Results due to Reagent Carryover from the Iron_2 Assay. This defect occurs only when a microalbumin test is run immediately after an iron test.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of AR, AU, AT, BS,…Official notice → - 2022-07-20
- US
Siemens Healthcare Diagnostics Inc recalls epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or…
Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.
Other drugs & medical recalls in the United States
- 2022-10-05
- US
Angiodynamics, Inc. recalls VenaCure EVLT KIT WITH SPOTLIGHT OPS SHEATH 55CM Ref./ Catalog No.: EVLT55OPS (each box contains 5 Procedure Kits). For use in the…
OPS Fiber packaged within specific VenaCure EVLT Procedure Kits does not meet the required dimensional specification, may result in damage to the sheath, including separation or the inability to move the fiber within…
FDA · DeviceAngiodynamics, Inc.US Nationwide distribution in the states of FL, NC, NJ, NM, NY, PA, TX, VA.Official notice → - US
DICOM Grid, Inc. d/b/a Ambra Health recalls Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.
A race condition between the storage system and services database has the potential to revert edits made to patient information upon first ingestion of a study.
FDA · DeviceDICOM Grid, Inc. d/b/a Ambra HealthDomestic: AR, CA, CO, CT, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA,…Official notice → - US
Baxter Healthcare Corporation recalls Starling Monitor, Product code CMMST5 and Starling Monitor SV, Product code CMM-ST5 (same products); and accessories/spare parts…
Labeling has incorrect or incomplete Unique Device Identification (UDI) information; and the barcodes are not compliant with GS-1 standards.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide Distribution and government/military distribution.Official notice → - US
Olympus Corporation of the Americas recalls Olympus POWERSEAL 5MM, 37CM, CURVED JAW SEALER & DIVIDER, DOUBLE-ACTION Model Number: PS-0537CJDA. An electrosurgical device…
An out of specification component preventing the blue retention ring from keeping the rotation knob in place. This may result in a loose rotation collar and retention ring and cause delay of treatment
FDA · DeviceOlympus Corporation of the AmericasNationwide OUS: AUSTRALIA, CANADA , HONG KONG, CHINA, KOREAOfficial notice → - US
Tandem Diabetes Care Inc recalls t:slim X2 insulin pump; t:slim X2 insulin pump with Dexcom G5; t:slim X2 insulin pump with Basal-IQ technology; t: slim x2 insulin pump…
Insulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen Staying On, 4) Unexpected Open Loop, that can be mitigated with a…
FDA · DeviceTandem Diabetes Care IncUS: NC, OK, ME, NY, TX, LA, NE, FL, AZ, IL, OH, CA, AL, MI, UT, VA, MA, SC,…Official notice → - US
Unomedical A/S recalls Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821, 1002822, 1002823, and 1002824. Infusion sets used with…
The IFU incorrectly states the insulin fill value of two sizes of cannula which can result in an initial insulin infusion to be fewer units than intended.
FDA · DeviceUnomedical A/SDistribution was made to California. There was no government/military…Official notice →