Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
A potential for depressed results for Atellica CH A1c_E when processing Atellica CH RCRP on the same analyzer. Customers processing A1c_E and RCRP on separate analyzers are not impacted by the recall. The frequency and…
Read the official notice →- Date
- 2026-04-08
- Country
- United States
- Brand
- Siemens Healthcare Diagnostics
- Product
- Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
- Classification
- Class II
- Units
- Domestic: Nationwide Distribution International: Argentina, Australia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-06-17
USSiemens Healthcare Diagnostics, Inc. recalls Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice →- 2026-05-06
- US
Siemens Healthcare Diagnostics Inc recalls epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515;
Use of the affected product can result in discrepant low pH and measured Total Carbon Dioxide (mTCO2) results and corresponding calculated values in arterial, venous, and capillary patient samples. An erroneously low…
FDA · DeviceSiemens Healthcare Diagnostics IncWorldwide distribution - US Nationwide and the countries of Italy, Spain,…Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential imprecision in the Dimension CRE2 quality control (QC) and patient sample…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - 2026-03-11
- US
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL may report values between 6.2 mg/dL and 40.0 mg/dL.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2025-11-19
- US
Siemens Healthcare Diagnostics, Inc. recalls Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 / IMMULITE 2000 XPi instrument in combination with a Zebra barcode…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution in the state of CA and the countries of…Official notice → - 2025-11-05
- US
Siemens Healthcare Diagnostics, Inc. recalls Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog Number:…
The potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal to 5.3 pmol/L), when using specific lots identified by the firm on…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of AL, CA, DC, FL, ID,…Official notice →
Other drugs & medical recalls in the United States
- 2026-04-08
- US
Mentor Texas, LP. recalls Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High &…
Infusion sets may contain dull/blunt needle tip, which may be difficult to advance, and/or break.
FDA · DeviceMentor Texas, LP.Worldwide distribution - US Nationwide and the countries of Canada, Albania,…Official notice → - US
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;
Philips has identified instances where X-ray imaging may not be initiated or may occur intermittently when using the wired foot switch.
FDA · DevicePHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Domestic: Nationwide Distribution; International: Afghanistan, Albania,…Official notice → - US
BD KIESTRA LAB AUTOMATION recalls BD Kiestra" ReadA; Catalog No.: 446948.
In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the…
FDA · DeviceBD KIESTRA LAB AUTOMATIONDomestic: KS, MD, MN, NJ, TX, VA; International: Australia, Austria, Belgium,…Official notice → - US
Reflexion Medical, Inc. recalls RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00
Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to…
- US
ReCor Medical Inc. recalls Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product…
Due to firm distributing a nonconforming product that supposed to be scrapped and not for human use.
FDA · DeviceReCor Medical Inc.U.S. Nationwide distribution in the states of CA, CO, FL, KS, MO, NC, OH, TX,…Official notice → - US
Philips Respironics, Inc. recalls Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
FDA · DevicePhilips Respironics, Inc.Worldwide Distribution. US Nationwide, Argentina, Austria, Australia, Bosnia…Official notice →