Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor… — Class II medical device recall Z-0755-2013
Terminated recall by Ortho-Clinical Diagnostics, reported 2013-02-06, distributed nationwide. Some VITROS¿ Chemistry Products Vapor Adsorption Cartridge CAT No. 6800100 cartons incorrectly contain a Parti
| Recall number | Z-0755-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho-Clinical Diagnostics, Rochester, NY, United States |
| Recall initiated | 2012-12-13 |
| Classified | 2013-01-30 |
| Reported by FDA | 2013-02-06 |
| Terminated | 2018-07-05 |
| Distributed | Nationwide (US) |
| Countries outside the US | GB |
| Reason classes | specification failure |
| Model numbers | 0100, 680 |
Product
Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption Cartridge REF/CAT No. 680 0100. VITROS¿ Vapor Adsorption Cartridges are used to remove vapor contaminants that may potentially interfere with Signal Reagent used with MicroWell Assays on the VITROS¿ 3600, VITROS¿ 5600, and VITROS¿ ECi/ECiQ Systems.
Reason for recall
Some VITROS¿ Chemistry Products Vapor Adsorption Cartridge CAT No. 6800100 cartons incorrectly contain a Particulate Cartridge Part No. J19612. In some instances, the Particulate Cartridge has been inadvertently installed on the VITROS¿ System instead of the intended VITROS¿ Vapor Adsorption Cartridge which may bias results.
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-0755-2013. 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.