The Recall Desk
SevereFDA (Devices)·Z-1647-2013·Announced 2013-07-10

Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS Chemistry Systems Due to Electrical Short

Ortho-Clinical Diagnostics is recalling 101 VITROS 5,1 FS Chemistry Systems because an electrical short can cause heat accumulation and melted wiring.

What this means for you

Illness, injury, or structural failure has been reported. 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 a Severe (4) rating involving significant injury or property damage risks.

Plain-English summary

Ortho-Clinical Diagnostics is recalling 101 units of the VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Chemistry System Refurbished. These devices are used for in vitro quantitative, semi-quantitative, and qualitative measurement of clinical analytes.

The recall is due to an electrical short within the systems connector that has caused heat accumulation. This heat has radiated back through the wiring harness, causing the wires and connectors to melt. The agency classifies this as a Class II recall.

A total of 101 units were distributed worldwide, including 84 units of product code 6801375 and 17 units of product code 6801890. Distribution included the United States and various international locations. Users should identify their units by the serial numbers listed in the official recall notice and contact the manufacturer for instructions.

The recalled product

Product
1) VITROS 5,1 FS Chemistry System (product code 6801375) and 2) VITROS 5,1 FS Chemistry System Refurbished (product code 6801890) Product Usage: For use in the in vitro quantitative, semi-quantitative, and qualitative measurement of a variety of analytes of clinical interest
Manufacturer
Ortho-Clinical Diagnostics
Category
Medical Device — Clinical Chemistry Analyzer
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)

  • Serial numbers: 1) J34000240
  • J34000714
  • J34001562 and J34002163 through J34002245
  • 2) 34000193
  • 34000420
  • 34000478
  • 34000495
  • 34000497
  • 34000529
  • 34000596
  • 34000799
  • 34000805
  • 34000947
  • 34001243
  • 34001422
  • 34001504
  • 34001569
  • 34001589
  • 34001610
  • 34001633

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 →

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