cobas b 221 AutoQC Module Complete — Class II medical device recall Z-1613-2018
Terminated recall by Roche Diagnostics Corporation, reported 2018-05-09, distributed nationwide. The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
| Recall number | Z-1613-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Roche Diagnostics Corporation, Indianapolis, IN, United States |
| Recall initiated | 2018-02-22 |
| Classified | 2018-05-03 |
| Reported by FDA | 2018-05-09 |
| Terminated | 2019-11-15 |
| Distributed | Nationwide (US) |
| Quantity | 1,026 products |
| Reason classes | software |
| Model numbers | 3313522001, 3313522692 |
Product
cobas b 221 AutoQC Module Complete; Catalog numbers: 3313522001 and 3313522692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.
Reason for recall
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
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-1613-2018. 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.