Ortho VITROS AFP Reagent Pack Recall Due to Calibration Failure
Ortho Clinical Diagnostics is recalling specific lots of VITROS AFP Reagent Packs because they may fail to calibrate, potentially affecting test results.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is unlikely to cause adverse health consequences. The issue is a functional failure (inability to calibrate) rather than a direct safety hazard like injury or death.
Plain-English summary
Ortho Clinical Diagnostics is recalling specific lots of VITROS Immunodiagnostic Products AFP Reagent Packs. The recall includes Lot 6471 and Lot 6480, which were distributed nationwide in the United States. The VITROS Immunodiagnostic Products AFP Calibrators are also included in the communication because they are lot-linked to the recalled reagent packs and cannot be used with other lots, although there is no known failure with the calibrators themselves.
The recall was initiated because the specific lots of reagent packs exhibit an increase in the reaction signal over time. This issue potentially results in the inability to calibrate and use the product. The product is used for the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum to aid in the management of patients with non-seminomatous testicular cancer.
Healthcare facilities and laboratories should stop using the affected lots of VITROS Immunodiagnostic Products AFP Reagent Packs and the associated lot-linked calibrators. Users should contact Ortho Clinical Diagnostics for further instructions regarding the return or disposal of the affected products.
The recalled product
- Product
- VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No.
- 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 (2)
- Lots 6471 (expiry date 19-Jul-2016)
- 6480 (expiry date 23-Aug-2016)
Distribution
Distributed nationwide across the United States.
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