Ortho-Clinical Diagnostics Recalls Worn CM/RT Incubator Wear Pads
Ortho-Clinical Diagnostics is recalling Colorimetric (CM)/ Rate (RT) incubator wear pads because they may become worn before their scheduled replacement.
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, and the source text does not report any illnesses, injuries, or deaths. The hazard is a mechanical component wearing out prematurely, which fits the criteria for a moderate severity recall involving a potential risk of harm without reported adverse events.
Plain-English summary
Ortho-Clinical Diagnostics is recalling Colorimetric (CM)/ Rate (RT) incubator wear pads, which are components used in the CM/RT incubator. The recall is due to the pads becoming worn before their intended replacement time.
The affected product codes are 6801375, 6801890, 6802445, and 6802413. These wear pads are used in the CM/RT incubator to process Microslide reagents with specific VITROS systems, including the VITROS 5,1 FS Chemistry System, VITROS 5,1 FS Chemistry System Refurbished, VITROS 4600 Chemistry System, and VITROS 5600 Integrated System.
The recall covers products distributed worldwide, including the United States (all states and Puerto Rico) and specific countries such as Mexico, Singapore, Venezuela, England, Germany, Italy, and Spain. Affected serial numbers include ranges J34000102 through J34002323, J46000108 through J46000312, and J56000110 through J56001779, along with a specific list of individual serial numbers provided in the source data.
The recalled product
- Product
- Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes: 1) 6801375, 2) 6801890, 3) 6802445, 4) 6802413 Product Usage: The CM/RT incubator processes Microslide reagents with the following VITROS systems: 1) VITROS 5,1 FS Chemistry System, 2) VITROS 5,1 FS Chemistry S
- 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)
- Serial Numbers: 1) J34000102 through J34002323
- 2) 34000133
- 34000193
- 4000212
- 34000316
- 34000318
- 34000337
- 34000360
- 34000420
- 34000451
- 34000478
- 34000495
- 34000497
- 34000529
- 34000538
- 34000552
- 34000557
- 34000596
- 34000601
- 34000631
Distribution
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