Z-1611-2018 Class II Terminated
FDA device recall Z-1611-2018 was initiated by Roche Diagnostics Corporation on Feb 22, 2018 and is designated Class II. Reason for recall: The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. The recall status is terminated (terminated Nov 15, 2019). Affected quantity: 1026 total products.
Recall Details
- Product Type
- Devices
- Report Date
- May 9, 2018
- Initiation Date
- Feb 22, 2018
- Termination Date
- Nov 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1026 total products
Product Description
Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 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.
Distribution Pattern
USA ( nationwide)
Code Information
Catalog numbers: 3337138001 and 3337138692 UDI: 04015630018321
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1611-2018
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026