Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the worst case, there is a potential for erroneously elevated lithium patient results, which may lead to inappropriate dosage…
Read the official notice →- Date
- 2022-10-26
- Country
- United States
- Brand
- Siemens Healthcare Diagnostics
- Product
- Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-01-18
USSiemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/…
Potential for Functional Sensitivity to not meet Instructions For Use (IFU) claims with the kit lots; control level one may result outside of published ranges; when control results are in range, users may observe…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Nationwide Foreign: Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿ Austria¿¿¿¿¿¿¿¿…Official notice →- 2022-12-21
- US
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SMN): 10711939 For the…
Potential for falsely elevated specific IgE mold allergen reactivity with quality control material and patient samples, may result in false reactive result
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution. US Nationwide, Argentina¿¿¿¿¿¿ Australia¿¿¿¿¿¿…Official notice → - 2022-12-14
- US
Siemens Healthcare Diagnostics, Inc. recalls IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers…
Confirmed an average positive bias of 40% for testosterone concentrations of approximately 660 ng/dL (22.9 nmol/L) and above with the IMMULITE/IMMULITE 1000 Total Testosterone Assay when compared to the IMMULITE…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide Distribution: US (nationwide) to states of: AL, CA, FL, GA, IN, KY,…Official notice → - 2022-10-26
- US
SIEMENS 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 →
Other drugs & medical recalls in the United States
- 2022-10-26
- US
Abbott Vascular recalls Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip…
An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be clip locking component material properties and certain use conditions.…
FDA · DeviceAbbott VascularWorldwide distribution - US Nationwide including in the states of PR, WA, NE,…Official notice → - US
Medicina Uk Ltd recalls Medicina Oral Tip Syringe 0.5ml Code: OT005
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
- US
MEDLINE INDUSTRIES, LP - Northfield recalls CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
One lot of chest tube insertion trays, containing a silk suture component that is restricted to 1 cycle of sterilization, was processed though 2 cycles.
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of CA and TX.Official notice → - US
BALT USA, LLC recalls Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Product pouch label does not match up with carton label
FDA · DeviceBALT USA, LLCWorldwide distribution - U.S. Nationwide distribution in the states of FL, GA,…Official notice → - US
ARROW INTERNATIONAL Inc. recalls ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For…
Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for…
FDA · DeviceARROW INTERNATIONAL Inc.US Nationwide distribution in the state of Florida.Official notice → - US
Synthes (USA) Products LLC recalls SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide…