The Recall Desk
ModerateFDA (Devices)·Z-1106-2013·Announced 2013-04-24

Ortho-Clinical Diagnostics Recalls VITROS 5,1 FS Chemistry Systems

Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems because extension springs may be out of specification, potentially causing imprecise test results.

What this means for you

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, but the source explicitly states that the probability of the defect adversely affecting results is unlikely and no injuries or illnesses are reported, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Ortho-Clinical Diagnostics, Inc. (OCD) is recalling VITROS 5,1 FS Chemistry Systems and VITROS 5,1 FS Chemistry System Refurbished units. The recall involves specific serial numbers for both product codes 6801375 and 6801890. These devices are intended for use in the measurement of a variety of chemistry analytes.

The recall was initiated after an internal evaluation at OCD's manufacturing facility discovered that extension springs on some systems may be out of manufacturing specifications. Specifically, an extension spring was found to have insufficient force. If the spring does not provide sufficient force, MicroSlides may not be properly positioned within the MicroSlide incubator, which has the potential to cause imprecise results. OCD's evaluation determined that the probability of an out-of-specification extension spring alone adversely affecting results is unlikely.

The affected units were distributed worldwide, including nationwide in the United States (including Puerto Rico) and in countries such as Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, the Republic of Panama, Singapore, Spain, and Venezuela. Users should check their device serial numbers against the list provided in the official recall notice to determine if their unit is affected.

The recalled product

Product
VITROS 5,1 FS Chemistry System, Product Code 6801375 and VITROS 5,1 FS Chemistry System Refurbished, Product Code 6801890. Intended for use in the measurement of a variety of chemistry analytes.
Manufacturer
Ortho-Clinical Diagnostics
Category
Medical Device — Laboratory Equipment
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)

  • VITROS 5
  • 1 FS Chemistry System Serial Numbers: 34000119 through 34002273
  • 1 FS Chemistry System Refurbished Serial Numbers: 34000133
  • 34001240
  • 34000193
  • 34001243
  • 34000212
  • 34001248
  • 34000316
  • 34001251
  • 34000318
  • 34001274
  • 34000337
  • 34001297
  • 34000360
  • 34001311
  • 34000420
  • 34001317
  • 34000451
  • 34001345

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 3 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 3 products in this recall →

Related recalls

Same manufacturer · Ortho-Clinical Diagnostics

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Same hazard · imprecise results

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