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.
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. 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 Sy
- Manufacturer
- Ortho-Clinical Diagnostics
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
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.
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