Z-0673-2017 Class II Terminated
FDA device recall Z-0673-2017 was initiated by Roche Diagnostics Operations, Inc. on Oct 31, 2016 and is designated Class II. Reason for recall: Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. QC measurement results can be affected as well. This issue is only detectable… The recall status is terminated (terminated Sep 18, 2017). Affected quantity: 97.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 7, 2016
- Initiation Date
- Oct 31, 2016
- Termination Date
- Sep 18, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 97
Product Description
MSS CASSETTE GLU/LAC/UREA (BUN) as a part of the Roche OMNI S Analyzer: cobas b 221<6>Roche OMNI S6 system 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
Incorrect Urea results may be generated sporadically on cobas b 221<6>Roche OMNI S6 system and cannot be detected by QC. QC measurement results can be affected as well. This issue is only detectable if comparison result of a second measurement is available. The cause for this issue is an error in the software measurement procedure. In children, decreased urea results can point at inborn disorders or urea cycle. Therefore, false normal urea values could lead to delayed/incorrect diagnosis of such a disorder. Besides the patients most at risk, the risk for the overall patient population with falsely low or high values is considered remote. No severe adverse health effects are expected; but, unnecessary diagnostic measures may be initiated. Falsely normal results may result in further necessary examination not being carried out, with the possibility of a delay in the diagnosis and treatment. A medical risk cannot entirely be excluded.
Distribution Pattern
Nationwide Distribution including ALCA CO CT FL IL IN KS MD MI MO NC NE NJ NM NY OH OK PA PR SC TX VA and WI
Code Information
Lot Number(s): All lots within shelf life. Expiration Date(s): All
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0673-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026