Ortho-Clinical Diagnostics Recalls VITROS CA 19-9 Reagent Packs and Calibrators
Ortho-Clinical Diagnostics is recalling VITROS CA 19-9 Reagent Packs and Calibrators, Lot 1320, because they may produce positively biased results on specific VITROS systems.
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 3/5 (High).
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 is classified as FDA Class II and involves a risk of harm (positively biased diagnostic results) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products CA 19-9 Total Reagent Packs and VITROS CA 19-9 Calibrators, Lot 1320. The recall involves 475 units that were distributed nationwide in the United States and internationally to France and Japan.
The recall was initiated because customers may receive positively biased results when using these products on VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic Systems, and VITROS 5600 Integrated Systems. The source text notes an unexpected observed change in the calibrator values for Lot 1320.
These products are used for the quantitative measurement of 1116-NS-19-9 defined antigen in human serum and plasma. The recall is classified as Class II by the FDA. No specific instructions for consumers are provided in the source text, but the affected products are identified by Lot 1320 and product codes 6800035 and 6800040.
The recalled product
- Product
- VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs, Lot 1320 VITROS¿ CA 19-9 Reagent Packs are used on VITROS¿ ECi/ECiQ Immunodiagnostic Systems, VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600 Integrated Systems for the quantitative measurement of…
- Manufacturer
- ORTHO-CLINICAL DIAGNOSTICS
- Affected units
- 475
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 (2)
- Lot 1320
- Product code: 6800035 and 6800040
Distribution
Distributed nationwide across the United States.
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