Ortho VITROS Estradiol Reagent Recall Due to Fulvestrant Cross-Reactivity
Ortho Clinical Diagnostics is recalling VITROS Estradiol Reagent Packs because the drug Fulvestrant causes falsely high test results in postmenopausal women.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a diagnostic device that produces significantly inaccurate results (up to 4046% bias) for a specific patient population, posing a risk of misdiagnosis or inappropriate treatment, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Ortho Clinical Diagnostics is recalling VITROS Immunodiagnostic Products Estradiol Reagent Packs. The recall involves specific lots of the reagent used on VITROS ECi/ECiQ, 3600, and 5600 systems.
The firm identified a potential cross-reactivity between the drug Fulvestrant and the Estradiol assay. Internal investigations confirmed that postmenopausal females taking Fulvestrant may receive biased positive Estradiol results, with errors ranging from 1303% to 4046%.
The recall covers 1,620 units distributed domestically and 7,597 units distributed internationally. Affected lots include 1470, 1480, 1490, 1500, 1510, 1528, 1538, 1548, 1558, and 1568. Healthcare facilities should stop using the affected reagent packs and contact the manufacturer for instructions.
The recalled product
- Product
- VITROS Immunodiagnostic Products Estradiol Reagent Pack, Unique Device Identifier No. 10758750005017, REF/Catalog Number/Product Code 855 2630; IVD -- Ortho-Clinical Diagnostics, Pencoed, Bridgend CF35 5PZ, UK --- The VITROS Estradiol test is performed using the VITROS Estradiol
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (8)
- Lot numbers: 1470 (expiry date 02-Aug-16)
- 1480 (expiry date 05-Aug-16)
- 1490 (expiry date 10-Oct-16)
- 1500 (expiry date 10-Oct-16)
- 1510 (expiry date 01-Nov-16)
- 1528 (expiry date 01-Nov-16) 1538 (expiry date 14-Mar-17)
- 1548 (expiry date 09-Mar-17)
- 1558 (expiry date 09-Mar-17) and 1568 (expiry date 29-Mar-17)
Distribution
Related recalls
Same manufacturer · ORTHO-CLINICAL DIAGNOSTICS
See all →- HighClinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
FDA (Devices) · 2024-04-03
- HighLaboratory performance verifier recalled for mismatched diluent assembly
FDA (Devices) · 2024-04-03
- HighFDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
FDA (Devices) · 2023-08-16
- HighVITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells
FDA (Devices) · 2023-08-16
- HighOrtho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias
FDA (Devices) · 2023-07-19
Same hazard · cross reactivity
See all →- HighFDA Recalls COVID-19 Antibody Test Kits for Increased False Positive Risk
FDA (Devices) · 2021-09-08
- ModerateCytocell Recalls Chromosome X Alpha-Satellite Probes Due to Cross-Reactivity
FDA (Devices) · 2021-05-05
- ModerateBeckman Coulter Recalls Synchron Opiate 2000 ng Reagent Due to Cross-Reactivity
FDA (Devices) · 2020-04-29
- ModerateTosoh Bioscience Recalls ST AIA-PACK Progesterone III Assay Kits
FDA (Devices) · 2018-03-07
- HighTosoh Bioscience Recalls Progesterone II Assay Kits Due to Cross-Reactivity
FDA (Devices) · 2018-03-07