Agency classClass IIIOur severity:Low FDA (Devices)·Z-2804-2016·Announced 2016-09-21

Ortho-Clinical Diagnostics Recalls VITROS Chemistry Calibrator Kit 31

Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 31, Lot 3155, because an incorrect value on the Assay Data Disks prevents successful calibration of the HbA1c assay.

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 FDA classified this recall as Class III, which by definition indicates that use of or exposure to the product is not likely to cause adverse health consequences. The issue is a data error preventing calibration, not a direct physical or chemical hazard.

Plain-English summary

Ortho-Clinical Diagnostics is recalling 520 units of the VITROS Chemistry Products Calibrator Kit 31, Lot 3155. This product is used in conjunction with the VITROS Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN 6) and Assay Data Disks (ADD) with Data Release Versions 5873, 5874, 5875, or 5876. The kit is used to calibrate the VITROS 5,1 FS Chemistry System, VITROS 4600 Chemistry System, and the VITROS 5600 Integrated System for the determination of percent glycated hemoglobin (HbA1c) in human whole blood.

The recall is due to an incorrect value (data/calibration mathematics) on the Assay Data Disks. This incorrect value will prevent a successful calibration of the assay. The FDA has classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.

The affected product was distributed worldwide, including nationwide in the United States and in various foreign countries. Users of the VITROS systems should check their inventory for Calibrator Kit 31, Lot 3155, and contact Ortho-Clinical Diagnostics for further instructions.

The recalled product

Product: The VITROS¿ Chemistry Products Calibrator Kit 31, Lot 3155 used in conjunction with: VITROS¿ Chemistry Products HbA1c Reagent Kit, Generation 6 (GEN 6) and Assay Data Disk (ADD), Data Release Versions (DRV) 5873, 5874, 5875, or 5876, is used to calibrate the VITROS 5,1 FS…
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — Laboratory Reagents
Hazard: mis-labeling
Affected units: 520

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 (1)

Lot 3155 Product Codes: 6842906 & 6801876

Distribution

Distributed nationwide across the United States.

The notice also names 28 states specifically:

Same manufacturer · Ortho-Clinical Diagnostics

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