Colorimetric — Class II medical device recall Z-1948-2013
Terminated recall by Ortho-Clinical Diagnostics, reported 2013-08-21, distributed nationwide. Ortho Clinical Diagnostics is recalling CM/RT wear pads which are a component in the CM/RT incubator due to be
| Recall number | Z-1948-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2013-06-06 |
| Classified | 2013-08-09 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2018-05-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | DE, ES, GB, IT, MX, SG, VE |
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 System Refurbished, 3) VITROS 4600 Chemistry System (VITROS 5,1 FS System family member), VITROS 5600 Integrated System.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1948-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.