Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0318-2014·Announced 2013-11-27

Ortho-Clinical Recalls VITROS Chemistry Slide Dispense Cartridges

Ortho-Clinical Diagnostics is recalling VITROS Chemistry Slide Dispense cartridges due to slide dispense issues.

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. The source text cites 'slide dispense issues' as the reason, which is a functional defect rather than a direct safety hazard like infection or injury. No illnesses or injuries are reported in the source text, and the defect is mechanical/operational rather than a high-risk pathogen or structural failure leading to immediate harm.

Plain-English summary

Ortho-Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides. The recall is being conducted due to slide dispense issues.

The affected products are VITROS Chemistry Products Mg Slides, which are used to quantitatively measure magnesium concentration in serum, plasma, and urine. These slides are compatible with VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated System. The recall includes slides packaged as 300 slides/pack (catalog number 8255093) and 90 slides/pack (catalog number 1921204).

A total of 101,976 units are affected, with 39,909 units distributed domestically in the United States and 62,067 units distributed internationally. The distribution covers all 50 US states, DC, Puerto Rico, and various countries including Australia, Brazil, Canada, and others. Multiple lots are affected, with expiry dates through March 22, 2015.

The recalled product

Product: VITROS Chemistry Products Mg Slides packaged as 300 slides/pack catalog number 8255093 and packaged as 90 slides/pack catalog number 1921204 VITROS Mg Slides quantitatively measure magnesium (Mg) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600…
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — In Vitro Diagnostics
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