Agency classClass IIOur severity:Severe FDA (Devices)·Z-1650-2013·Announced 2013-07-10

Ortho-Clinical VITROS 3600 Immunodiagnostic System Recalled for Electrical Short

Ortho-Clinical Diagnostics is recalling VITROS 3600 Immunodiagnostic Systems because an electrical short caused heat accumulation that melted wiring and connectors.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a structural defect (electrical short causing melting) in a medical device, which aligns with the rubric criteria for 'Severe' severity (structural vehicle defect or significant injury/property-damage reports).

Plain-English summary

Ortho-Clinical Diagnostics is recalling 98 units of the VITROS 3600 Immunodiagnostic System (product code 6802783). The recall affects serial numbers J36000111 and J36000520 through J36000617. The affected units were distributed worldwide, including nationwide in the United States and in various international markets.

The recall was initiated because there is evidence that an electrical short within the system's connector caused an accumulation of heat. This heat radiated back through the wiring harness, causing the wires and connectors to melt. The product is used for in vitro quantitative, semi-quantitative, and qualitative measurement of clinical analytes.

Users of the VITROS 3600 Immunodiagnostic System should contact Ortho-Clinical Diagnostics for instructions on how to stop using the affected units and arrange for repair or replacement.

The recalled product

Product: VITROS 3600 Immunodiagnostic System (product code 6802783) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest, using VITROS Immunodiagnostic Products Reagents
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — In Vitro Diagnostics
Hazard: electrical-short
heat-accumulation
melting

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)

Serial numbers: J36000111 and J36000520 through J36000617

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Part of a larger recall action

This product is one of 5 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 5 products in this recall →

Same manufacturer · Ortho-Clinical Diagnostics

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Same hazard · electrical short