Recall archive
128 recalls · page 1 of 6
Reported Sep 24, 2025
Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
Matched: Brand — VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 27, 2025
VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
Matched: Brand · Reason for recall — Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400…
FDA (openFDA device enforcement)
Reported Jul 23, 2025
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier I Model/Catalog…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
Matched: Brand — Quality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 9, 2025
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: (1) 6802413, (2) 6802915
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
Matched: Brand — A software anomaly allows test results to be reported using Micro Tip and Micro Slide diluent packs that the system treats as expired even when the…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2025
Brand Name: Solana¿ Bordetella Complete Assay Product Name: Solana Bordetella kit Model/Catalog Number: M308 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
Matched: Brand — It was determined that there could be a false positive rate of up to 16.7% for the affected lots associated with the Bordetella parapertussis (BPP)…
FDA (openFDA device enforcement)
Reported Jun 4, 2025
VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
Matched: Brand — Product was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label.
FDA (openFDA device enforcement)
Reported Jan 29, 2025
Brand Name: VITROS Product Name: VITROS 5600 Integrated System Model/Catalog Number: 6802413 (New), 6802415…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
Matched: Brand · Product details — The VITROS 5600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 4, 2024
VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
Matched: Brand · Product · Product details — May Generate Negatively Biased Results When Testing Samples with High Concentrations of CRP, showing less than upper AMI of 90 mg/L (in the 70-90…
FDA (openFDA device enforcement)
Reported Aug 28, 2024
The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
Matched: Brand · Reason for recall — The reason for this recall is QuidelOrtho has determined that during normal use the VITROS XT ALB-TP Slides may shed dust and debris as they travel…
FDA (openFDA device enforcement)
Reported Aug 21, 2024
VITROS Immunodiagnostic VITROS Folate Reagent Pack 1/2
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
Matched: Brand — It was confirmed that fibrinogen in patient plasma samples precipitates out of solution upon the addition of folate stabilizer reagent as part of the…
FDA (openFDA device enforcement)
Reported Jul 10, 2024
VITROS Chemistry Products Calibrator Kit 29- In-Vitor used to calibrate the VITROS 5,1 FS/4600 Chemistry Systems and…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ortho-Clinical Diagnostics, Inc.
Matched: Brand — Kit assigned an extended expiration date of 24-Jul-2025 during release. The correct expiration date for Lot 2953 is 24-Jul-2024. If used past its…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 19, 2024
VITROS Immunodiagnostic Products Anti HBs Calibrators. The VITROS Anti-HBs Calibrator Pack contains 3 X labelled…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
Matched: Brand — Potential for positively biased results due to signal reduction over shelf life.
FDA (openFDA device enforcement)
Reported Jun 12, 2024
VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. For use in verifying the…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ortho-Clinical Diagnostics, Inc.
Matched: Brand · Product · Product details — The results generated by the VITROS Immunodiagnostic Products Vitamin B12 Range Verifier Lot# 1200 RV Level 2 may cause range verification failure.…
FDA (openFDA device enforcement)
Reported Apr 3, 2024
VITROS Performance Verifier I
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand — The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Mar 13, 2024
VITROS 3600 Immunodiagnostic System (New and Refurbished)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
Matched: Brand — Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿…
12 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 31, 2024
VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack, Catalog No. 6801925 VITROS Immunodiagnostic…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
Matched: Brand — Affected lots may experience increased calibration failures or an increase in falsely elevated results.
FDA (openFDA device enforcement)
Reported Jan 17, 2024
QMS Tacrolimus Calibrators, Product code 10015573
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
Matched: Brand · Reason for recall — Ortho-Clinical Diagnostics, Inc. is recalling QMS Tacrolimus Calibrators, Lot 74859619 expiry date: May 11, 2024, due to improper storage that is…
FDA (openFDA device enforcement)
Reported Dec 20, 2023
VITROS 3600 Immunodiagnostic System Product Code 6802783 and Refurbished Product Code 6802914 Running Software Version…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
Matched: Brand · Reason for recall — During planned monitoring of data post-release of Software Version 3.8.0 an increased occurrence of software issues relating to unresponsive…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2023
VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
Matched: Brand · Product · Product details · Reason for recall — Ortho Clinical Diagnostics (QuidelOrtho) confirmed during routine testing that some lots from Coating 3598 of VITROS ECO2 slides included carts which…
FDA (openFDA device enforcement)
Reported Nov 15, 2023
VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
Matched: Brand · Reason for recall — Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on…
FDA (openFDA device enforcement)
Reported Oct 11, 2023
Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
Matched: Brand · Reason for recall — Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactured between 07-Apr-2022 (Date code: 040722) and…
FDA (openFDA device enforcement)
Reported Sep 27, 2023
VITROS XT Chemistry Products TBIL-ALKP Slides
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics, Inc.
Matched: Brand · Reason for recall — Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 16, 2023
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Ortho-Clinical Diagnostics
Matched: Brand — Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Aug 2, 2023
VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Ortho-Clinical Diagnostics, Inc.
Matched: Brand · Product · Product details — May not meet the stability specifications for shelf life outlined in the Instructions For Use (IFU).
FDA (openFDA device enforcement)
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