FDA Device recall Z-1613-2018
cobas b 221 AutoQC Module Complete
- FDA Device
- Class II
- terminated
- Published 2018-05-09
On 2018-05-09 the FDA classified a Class II recall of cobas b 221 AutoQC Module Complete by Roche Diagnostics, citing the software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1613-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-22 |
| Published | 2018-05-09 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Roche Diagnostics |
| Distribution | US |
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
The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate.
Identifiers
| code_info | Catalog numbers: 3313522001 and 3313522692 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1613-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.