| Class 2 Device Recall AutoQC Module Complete Cobas b 221 | |
Date Initiated by Firm | February 22, 2018 |
Date Posted | May 03, 2018 |
Recall Status1 |
Terminated 3 on November 15, 2019 |
Recall Number | Z-1613-2018 |
Recall Event ID |
79676 |
510(K)Number | K032311 |
Product Classification |
Electrode, ion specific, potassium - Product Code CEM
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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. |
Code Information |
Catalog numbers: 3313522001 and 3313522692 |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corporation 9115 Hague Rd Indianapolis IN 46256-1025
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For Additional Information Contact | Roche Support Network Customer Support Center 800-526-2272 |
Manufacturer Reason for Recall | The software responsible for starting scheduled AutoQC measurements (scheduler) will not activate. |
FDA Determined Cause 2 | Software design |
Action | ROCHE sent an Urgent Medical Device Correction Letter dated February 22, 2018, via UPS to affected customers.
Customers were instructed to complete the following: " 1) Use the Return to Setup and Exit buttons to ensure execution of scheduled AutoQC measurements as described in this Urgent Medical Device Correction (UMDC); 2) Check to see if the next scheduled AutoQC measurement is performed to ensure the AutoQC scheduler is working as expected; 3) If your facility has distributed the affected product to another site, please ensure this UMDC is provided to that site; 4) Complete the attached fax form (TP-00146) and fax it to 1-844-491-7776 or scan and email to roche7570@stericycle.com; 5) File this UMDC for future reference.
Customers with questions should contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-526-2272. |
Quantity in Commerce | 1026 total products |
Distribution | USA ( nationwide) |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = CEM
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