Ortho-Clinical VITROS 5,1 FS Chemistry System Recalled for Biased Results
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems due to a potential for biased results when specific Multiple Window codes are used.
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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Ortho-Clinical Diagnostics is recalling VITROS 5,1 FS Chemistry Systems and VITROS 5,1 FS Refurbished units. The recall involves product codes 6801375 and 6801890, which are intended for in vitro diagnostic use. The affected units include specific serial numbers and software version 2.7 and below.
The recall is issued because of a potential for biased results when a Multiple Window (MW) code is associated with results generated by the VITROS 4600 Chemistry System, the VITROS 5600 Integrated System, and the VITROS 5,1 Chemistry System. These MW codes may be associated with results from VITROS Chemistry Products using multiple point (multipoint) rate measurements, which could affect specific MicroSlide assays.
The recall covers 597 domestic units and 1,381 foreign units. Distribution was worldwide, including the United States, Puerto Rico, Australia, Brazil, Canada, Chile, China, Colombia, England, France, Germany, India, Italy, Japan, Mexico, Panama, Singapore, Spain, and Venezuela. Users should contact Ortho-Clinical Diagnostics for instructions on how to proceed.
The recalled product
- Product
- VITROS 5,1 FS Chemistry System and VITROS 5,1 FS Refurbished, Product Codes/Catalog Numbers 6801375, 6801890 for in vitro diagnostic use.
- Manufacturer
- Ortho-Clinical 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 2.7 and below
- VITROS 5
- 1 FS Chemistry System Serial Numbers: J34000102 through J34002323
- 1 FS Chemistry System Refurbished Serial Numbers: ¿34000337
- ¿34001840
- ¿34000316
- ¿34001389
- 34001317
- ¿34000538
- ¿34000552
- ¿34000360
- ¿34000451
- ¿34000833
- ¿ 34001572
- ¿34000193
- ¿34001633
- ¿34000851
- ¿34001345
- ¿34001396
- 34001809
Distribution
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.
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