The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1075-2016·Announced 2016-03-16

Ortho-Clinical VITROS 5,1 FS Chemistry System Recall for Software Defect

Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to increased error codes generated when using a specific calibrator lot.

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 hazard involves software error codes and customer response trends rather than direct physical injury or high-risk pathogen exposure, fitting the criteria for moderate severity.

Plain-English summary

Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems, including both new and refurbished units, due to a software issue. The recall affects systems running Software Version 2.8 and below. The issue involves the generation of increased U90-382 or 6LU condition codes when the systems are used with Calibrator Kit 9, Lot 954.

The recall was initiated after a trend of complaints was noted regarding customer actions taken in response to these specific condition codes. This recall is associated with a previous recall of the VITROS Calibrator Kit 9, Lot 954 (RES 72289). The affected devices are intended for in vitro quantitative measurement of clinical analytes.

The recall covers 994 units in the United States and 1,405 units distributed worldwide. Distribution includes the US (including Puerto Rico) and countries such as Australia, Brazil, Canada, and others. Users should check their software version and serial numbers against the recall list to determine if their device is affected.

The recalled product

Product
VITROS 5,1 FS Chemistry System, Catalog Number 6801375, Unique Device Identifier Number 10758750001132; and VITROS 5,1 FS Chemistry System (Refurbished), Catalog Number 6801890, Unique Device Identifier Number 10758750001644; IVD. Product Usage: The VITROS 5,1 FS Chemistry…
Manufacturer
Ortho-Clinical Diagnostics
Category
Medical Device — In Vitro Diagnostics
Hazard

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 2.8 and below
  • VITROS 5
  • 1 FS Chemistry System Serial Numbers: J34000119 - J34002323
  • 1 FS Chemistry System (Refurbished) Serial Numbers: 34000133
  • 34000193
  • 34000197
  • 34000212
  • 34000285
  • 34000316
  • 34000318
  • 34000337
  • 34000360
  • 34000420
  • 34000451
  • 34000478
  • 34000495
  • 34000497
  • 34000529
  • 34000538
  • 34000552

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 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 →

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