Agency classClass IIOur severity:High FDA (Devices)·Z-1914-2016·Announced 2016-06-15

Ortho VITROS 5600 System Recalled for Software Timing Anomaly

Ortho-Clinical Diagnostics is recalling VITROS 5600 systems due to a software defect that may cause sample aspiration errors, leading to inaccurate or contaminated test results.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential for erroneous or contaminated results which could lead to adverse health consequences, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Ortho-Clinical Diagnostics is recalling the VITROS 5600 Integrated System and VITROS 5600 Integrated System (refurbished) due to a confirmed software timing anomaly. The affected units are identified by specific catalog numbers and serial numbers, with software versions 3.2.2 and below.

The software defect may cause the system to unexpectedly aspirate from or dispense into an unintended sample. This malfunction can lead to erroneous or contaminated test results, which may impact clinical decision-making. The recall covers units distributed nationwide in the United States, Puerto Rico, and various foreign countries.

Healthcare facilities and laboratories should stop using the affected VITROS 5600 systems and contact Ortho-Clinical Diagnostics for instructions on how to resolve the issue. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: VITROS 5600 Integrated System, Catalog Number 6802413, Unique Device Identifier No. 10758750002740; and VITROS 5600 Integrated System (refurbished), Catalog Number 6802915, Unique Device Identifier No. 10758750007110; IVD.
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — In Vitro Diagnostics
Hazard: software-defect
contamination
erroneous-results

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 (20)

Software Version 3.2.2 & below
VITROS 5600 Serial Numbers J56000024 - J56002387
VITROS 5600 (Refurbished) US Serial Numbers: 56000186
56000308
56000315
56000327
56000339
56000458
56000559
56000718
56000727
56000741
56000747
56000750
56000786
56000792
56000824
56001062
56001235
56001635

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 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 2 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 · software defect