Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products PHYT Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides due to a potential for imprecise results in quality control and patient samples.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves imprecise diagnostic results without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. The recall involves 5,712 units of the in vitro diagnostic product. The company has identified a potential for imprecise results when using the slides, specifically noting an increase in imprecision when using PHYT coating 0165.
This issue leads to higher and lower than expected results for both quality control samples and patient samples. The affected products were distributed worldwide, including in the United States, Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Portugal, Russia, Singapore, Spain, and Sweden. Specific lot numbers are listed in the agency's recall record.
Healthcare facilities and consumers should stop using the affected slides and contact Ortho-Clinical Diagnostics for further instructions on how to return or dispose of the product.
The recalled product
- Product
- VITROS Chemistry Products PHYT Slides, Catalog Number 8298671. in vitro diagnostic
- Manufacturer
- Ortho-Clinical Diagnostics
- Hazard
- Affected units
- 5,712
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 (20)
- Lot Numbers: 2616-0165-4866
- 2616-0165-4904
- 2616-0165-4870
- 2616-0165-4869
- 2616-0165-5266
- 2616-0165-5307
- 2616-0165-5233
- 2616-0165-5232
- 2616-0165-5611
- 2616-0165-5610
- 2616-0165-5648
- 2616-0165-5649
- 2616-0165-6218
- 2616-0165-6275
- 2616-0165-6220
- 2616-0165-6221
- 2616-0165-6219
- 2616-0165-6276
- 2616-0165-6791
- 2616-0165-6832
Distribution
Distributed nationwide across the United States.
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 · imprecise results
See all →- ModerateRandox Lipase Assay Buffer Recalled for Imprecision in Quality Control
FDA (Devices) · 2020-08-12
- ModerateBeckman Coulter PrepPlus 2 Recalled for Sample Preparation Imprecision
FDA (Devices) · 2017-07-12
- HighSiemens Healthcare Recalls Emit 2000 Phenobarbital Assay Due to Imprecision
FDA (Devices) · 2013-11-13
- ModerateOrtho-Clinical Diagnostics Recalls VITROS 4600 Chemistry Systems
FDA (Devices) · 2013-04-24
- ModerateOrtho-Clinical Diagnostics Recalls VITROS 5600 Integrated Systems
FDA (Devices) · 2013-04-24