Reported Aug 21, 2013 · Terminated
Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes
Ortho-Clinical Diagnostics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
Colorimetric (CM)/ Rate (RT) incubator wear pads. Product Codes
7 of 7 products
| # | Product as published |
|---|---|
| 1 | 6801375 |
| 2 | 6801890 |
| 3 | 6802445 |
| 4 | 6802413 Product Usage: The CM/RT incubator processes Microslide reagents with the following VITROS systems |
| 5 | VITROS 5,1 FS Chemistry System |
| 6 | VITROS 5,1 FS Chemistry System Refurbished |
| 7 | VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), VITROS 5600 Integrated System. |
- Lot codes and dates
4 of 4 products
Products covered by this recall # Product as published 1 J34000102 through J34002323 2 34000133, 34000193, 4000212, 34000316, 34000318, 34000337, 34000360, 34000420, 34000451, 34000478, 34000495, 34000497, 34000529, 34000538, 34000552, 34000557, 34000596, 34000601, 34000631, 34000642, 34000805, 34000833, 34000851, 34000893, 34000947, 34001172, 34001218, 34001240, 34001243, 34001248, 34001251, 34001274, 34001297, 34001311, 34001317, 34001345, 34001378, 34001389, 34001390, 34001396, 34001422, 34001472, 34001504, 34001569, 34001572, 34001589, 34001610, 34001612, 34001633, 34001668, 34001809, 34001840, 34001850, 34001897 3 J46000108 through J46000312 4 J56000110 through J56001779.
Where it was sold
Why it was recalled
Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to becoming worn before their replacement.
This product could cause temporary or reversible health problems — stop using it.
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