Recall archive
195 recalls · page 1 of 9
Reported Aug 26, 2026Updated Sep 7, 2026
Beckman Coulter, Emit 2000 Quinidine Assay REF: OSR4Q229 Contents: R1: 2 x 23 mL;R2 2x13 mL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 12, 2026
Syva Emit Disopyramide Assay Enzyme Immunoassay, Lidocaine SMN 10445370 Catalog No 6N319UL
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — Out-of-specification sodium azide concentration in Syva Emit Disopyramide Enzyme Immunoassay Calibrator Lot U1. While the assay results were not…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 15, 2026
Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed…
FDA (openFDA device enforcement)
Reported Jun 17, 2026
Siemens Dimension Tacrolimus Flex Reagent Cartridge (TAC), REF DF207, SMN 10700795; enzyme immunoassay
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge.
FDA (openFDA device enforcement)
Reported May 6, 2026
Dimension Creatinine Flex reagent cartridge. Material Number: 10872079.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Reason for recall — Siemens Healthcare Diagnostics is recalling certain lots of Dimension Creatinine Flex reagent cartridge (Dimension CRE2) because a potential…
FDA (openFDA device enforcement)
Reported Apr 8, 2026
Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details · Reason for recall — 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…
FDA (openFDA device enforcement)
Reported Mar 11, 2026
Atellica CH Urine Albumin (UAlb). Material Number: 11537225
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — Falsely depressed UAlb patient results may occur. Affected samples with any urine albumin concentration above the UAlb measuring interval >40.0 mg/dL…
FDA (openFDA device enforcement)
Reported Nov 19, 2025
IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2KUN6;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — The barcode orientation on affected devices causes incorrect scanning order of tubes within the allergen holder wedge. When using an IMMULITE 2000 /…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Nov 5, 2025
Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10381442; Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — 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…
FDA (openFDA device enforcement)
Reported Sep 17, 2025
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — Potential for falsely depressed patient, quality control (QC), and/or calibration results or delayed results.
FDA (openFDA device enforcement)
Reported Jul 9, 2025
ADVIA¿ 120/2120/2120i SETpoint Calibrator
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 2, 2025
Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays…
FDA (openFDA device enforcement)
Reported Jun 4, 2025
Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 16, 2025
Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — Incorrect software flagging may occur for the assay that may potentially lead to an erroneous result.
FDA (openFDA device enforcement)
Reported Jan 1, 2025
epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Intended for use by…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details · Reason for recall — Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a software malfunction that occurs when specific criteria are…
8 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 11, 2024
Atellica CI Analyzer. Catalog Numbers: 10947347.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — Potential that the IMT Diluent volume remaining (% remaining) does not decrease as expected on the Atellica CI Analyzer, potentially leading to the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 27, 2024
Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample reaction volumes…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 on the packaging or 15 on the underside of the…
FDA (openFDA device enforcement)
Reported Nov 20, 2024
IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not meet the High-dose Hook Effect claim as stated in…
FDA (openFDA device enforcement)
Reported Oct 9, 2024
ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — Positive bias in patient results at and below the cut-off of 60 U/mL with the lots listed in the table below when compared to alternate lots on the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 25, 2024
Atellica CH Microalbumin_2 (¿ALB_2)-For in vitro diagnostic use in the quantitative measurement of microalbumin in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — Atellica CH Microalbumin_2 (¿ALB_2) and the ADVIA Chemistry Microalbumin_2 (¿ALB_2) are not meeting the High-Dose Hook Effect claim/Prozone Effect…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 18, 2024
Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product · Product details — The potential for biased quality control (QC) and patient results when using Atellica CH UCFP lot 130414 and ADVIA Chemistry UCFP lot 140 reagents.
7 more products in this recall
FDA (openFDA device enforcement)
Reported May 29, 2024
IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoantibody.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand — The potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Apr 24, 2024
Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithium heparin and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Product details — Potential for falsely elevated Chol_2, LDLC, and Trig_2 results on the Atellica CH and Atellica CI analyzers when the previous result in the cuvette…
FDA (openFDA device enforcement)
Reported Mar 27, 2024
DCA Systems HbA1c Reagent Kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Siemens Healthcare Diagnostics, Inc.
Matched: Brand · Reason for recall — The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential…
FDA (openFDA device enforcement)
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