—#150817

Product

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

FDA product code: CDS — Electrode, Ion Specific, Urea Nitrogen
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K032311
Affected lot / code info: Lot Number(s): All lots within shelf life. Expiration Date(s): All

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

Roche sent an Urgent Medical Correction letter dated October 31, 2016, to all affected customers. The recall notifications included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Actions Required " Use the workaround outlined in this Urgent Medical Device Correction (UMDC) for Urea measurement until the updated software version is available. " If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site. " Complete the attached fax form and fax it to 1-877-766-7471. " File this UMDC for future reference. Questions Please contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272 if you have questions about the information contained in this UMDC.

Recalling firm

Firm: Roche Diagnostics Operations, Inc.
Address: 9115 Hague Rd, Indianapolis, Indiana 46256-1025

Distribution

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

Timeline

Recall initiated: 2016-10-31
Terminated: 2017-09-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #150817. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.