The Recall Desk
ModerateFDA (Devices)·Z-1071-2016·Announced 2016-03-16

Ortho-Clinical VITROS 250 Chemistry Systems Recalled for Condition Code Errors

Ortho-Clinical Diagnostics is recalling VITROS 250 Chemistry Systems due to increased U90-382 or 6LU condition codes generated when using Calibrator Kit 9, Lot 954.

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 FDA classified this as a Class II recall. The source text describes a trend of complaints regarding customer actions following condition codes, but does not explicitly report injuries, illnesses, or deaths, fitting the criteria for a moderate severity precautionary or labeling/functional error recall.

Plain-English summary

Ortho-Clinical Diagnostics is recalling VITROS 250 Chemistry Systems (Catalog 8132086 and 6801759) and VITROS 250 Refurbished units. The recall involves 802 units in the United States and 2,472 units distributed worldwide, including Australia, Brazil, Canada, and other countries.

The recall is due to an increased frequency of U90-382 or 6LU condition codes generated by the systems when using Calibrator Kit 9, Lot 954. A trend of complaints was noted regarding customer actions taken in response to these condition codes. This issue is related to a previous recall of VITROS Calibrator Kit 9, Lot 954 (RES 72289).

The affected units are identified by Software Version 9.4 and below, along with specific serial numbers listed in the recall documentation. The FDA has classified this as a Class II recall. Users should contact Ortho-Clinical Diagnostics for instructions on how to address the issue.

The recalled product

Product
VITROS 250 Chemistry Systems, Catalog 8132086, Unique Device Identifier No. 10758750004409, and VITROS 250 Refurbished, Catalog 6801759, Unique Device Identifier No. 10758750001330; IVD. Product Usage: For in vitro diagnostic use. The VITROS 250 Chemistry System performs disc
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 9.4 and below
  • VITROS 250 Serial Numbers: 25010043 - 25055306
  • VITROS 250 Refurbished Serial Numbers: 25010582
  • 25010617
  • 25010638
  • 25010782
  • 25011056
  • 25011074
  • 25011176
  • 25011192
  • 25011196
  • 25011246
  • 25011317
  • 25011383
  • 25011408
  • 25011435
  • 25011448
  • 25011517
  • 25011647
  • 25011648

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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