Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0314-2014·Announced 2013-11-27

Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product GLU Slides

Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product GLU Slides due to slide dispense issues. The recall affects 349,072 units distributed worldwide.

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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product GLU Slides, packaged as 300 slides per pack (catalog number 1707801), due to slide dispense issues. These slides are used with VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System to quantitatively measure glucose concentration in serum, plasma, urine, and cerebrospinal fluid.

The recall involves 349,072 units, with 142,455 units distributed domestically in the United States and 205,617 units distributed internationally. The affected lots have expiry dates through March 22, 2015. Distribution was nationwide in the US, including Puerto Rico, and internationally to countries including Australia, Brazil, Canada, and others.

Healthcare facilities and consumers should stop using the affected VITROS Chemistry Product GLU Slides and contact Ortho-Clinical Diagnostics for further instructions on returns or replacements.

The recalled product

Product: VITROS Chemistry Products GLU Slides packaged as 300 slides/pack catalog number 1707801 VITROS GLU Slides quantitatively measure glucose (GLU) concentration in serum, plasma, urine and cerebrospinal fluid using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS…
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — Laboratory Reagents
Hazard: functional-defect

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)

Multiple lots affected
with expiry dates through 22-Mar-2015

Distribution

Distributed nationwide across the United States.

The notice also names 50 states specifically:

Part of a larger recall action

This product is one of 37 recalled by Ortho-Clinical Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 37 products in this recall →

Same manufacturer · Ortho-Clinical Diagnostics

See all →

High
Clinical Laboratory Quality Control Device Recalled for Diluent Assembly Error
FDA (Devices) · 2024-04-03
High
Laboratory performance verifier recalled for mismatched diluent assembly
FDA (Devices) · 2024-04-03
High
VITROS Troponin I ES Immunodiagnostic Reagent Pack Recalled for Incorrect Wells
FDA (Devices) · 2023-08-16
High
FDA Recalls Troponin Cardiac Test Calibrators for Potential False Negatives
FDA (Devices) · 2023-08-16
High
Ortho Recalls VITROS Chemistry Calibrator Kit 20 for Analytical Bias
FDA (Devices) · 2023-07-19

Same hazard · functional defect