| Class 2 Device Recall VITROS 4600 Immunodiagnostic System | |
Date Initiated by Firm | January 26, 2024 |
Date Posted | March 01, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1225-2024 |
Recall Event ID |
93925 |
510(K)Number | K031924 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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Product | VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished) |
Code Information |
VITROS System Software Version 3.8.1
Regular UDI-DI 10758750012343
Refurbished UD-DI 10758750033201
Serial Numbers
US: J46000240
J46000898
J46001030
J46001293
OUS: J46000150 J46001041
J46000190 J46001042
J46000499 J46001186
J46000564 J46001187
J46000801 J46001210
J46000821 J46001217
J46000910 J46001289
J46000933 J46001639
J46001029 J46001645
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Recalling Firm/ Manufacturer |
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr Rochester NY 14626-5101
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For Additional Information Contact | Mr. Joe Falvo 585-453-3000 |
Manufacturer Reason for Recall | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported. |
FDA Determined Cause 2 | Software Design Change |
Action | On January 26, 2024, the firm sent a customer letter to all customers who have V3.8.1 installed on their VITROS Analyzer. Customers were informed of this issue and instructed to follow the instructions when using the VITROS System onboard QC package to update the QC baseline.
The software will be updated to mitigate both issues within the VITROS Software QC feature. The estimated availability is 2Q2024.
If you have further questions, please contact Global Services Organization at 1-800-421-3311. |
Quantity in Commerce | 4 US; 18 OUS |
Distribution | Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA, ID, IL, IN, KY,
LA, MO, NE, NY, OH, OR, SC, SD, TX, WA, WI, WV and the countries of Australia, Brazil, Canada, China, Colombia, India, Mexico, Singapore, United Kingdom, Italy, Spain, Russia, France, and Belgium.
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database | 510(K)s with Product Code = JJE
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