Ortho-Clinical VITROS Hand-held Barcode Scanner Recall for Sample Skipping
Ortho-Clinical Diagnostics is recalling VITROS Hand-held Barcode Scanners because they may skip sample cup positions when using the Batch Programming option.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 defect involves a functional error in sample programming that could impact testing accuracy, but no injuries or illnesses are reported in the source text.
Plain-English summary
Ortho-Clinical Diagnostics is recalling the VITROS Hand-held Barcode Scanner, Catalog Number 6844210. This accessory is used with VITROS 5,1 FS Chemistry, VITROS 3600 Immunodiagnostics, VITROS 4600 Chemistry, and VITROS 5600 Integrated Systems. The recall covers 62 units distributed in the United States and 10 units distributed in Canada, Australia, and England.
The recall is due to a defect where the scanner unexpectedly skips sample cup positions within a sample tray. This issue occurs only when using the Batch Programming option for programming samples; all other sample programming options function as intended.
Users of the affected scanners should stop using the Batch Programming option. Ortho-Clinical Diagnostics is the recalling firm responsible for addressing this issue.
The recalled product
- Product
- VITROS Hand-held Barcode Scanner, Catalog Number 6844210, for use with the following VITROS Systems: VITROS 5,1 FS Chemistry System, VITROS 3600 Immunodiagnostics System, VITROS 4600 Chemistry System, VITROS 5600 Integrated System. This product is an accessory for use with…
- 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 (20)
- Lot Numbers: 0914F11968
- 0914F11969
- 0914F11970
- 0914F11971
- 0914F11972
- 0914F11973
- 0914F11974
- 0914F11975
- 0914F11976
- 0914F11977
- 0914F11978
- 0914F11979
- 0914F11980
- 0914F11981
- 0914F11982
- 0914F11983
- 0914F11984
- 0914F11985
- 0914F11986
- 0914F11987
Distribution
Distributed nationwide across the United States.
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