Agency classClass IIIOur severity:Low FDA (Devices)·Z-2145-2016·Announced 2016-07-20

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.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

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…
Manufacturer: ORTHO-CLINICAL DIAGNOSTICS
Category: Medical Device — In Vitro Diagnostics
Hazard: functional-failure
calibration-error

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.

Same manufacturer · ORTHO-CLINICAL DIAGNOSTICS

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