| Class 2 Device Recall VITROS XT 3400 Chemistry System |  |
Date Initiated by Firm | January 26, 2024 |
Date Posted | March 01, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1232-2024 |
Recall Event ID |
93927 |
510(K)Number | K182063 |
Product Classification |
Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
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Product | VITROS XT 3400 Chemistry System, Catalog No. 6844458 |
Code Information |
VITROS System Software Versions 3.8.0 or 3.8.1
UDI-DI 10758750031986
Serial Numbers:
US:
J34500140
J34500180
J34500257
J34500289
J34500319
J34500386
J34500422
J34500447
J34500473
J34500474
J34500510
J34500539
J34500547
J34500579
J34500588
J34500622
J34500656
J34500777
J34500818
J34500861
J34500887
J34500893
J34500896
J34500911
J34500931
OUS:
J34500123
J34500128
J34500129
J34500130
J34500190
J34500261
J34500269
J34500271
J34500292
J34500301
J34500337
J34500356
J34500363
J34500515
J34500520
J34500536
J34500582
J34500609
J34500628
J34500658
J34500711
J34500793
J34500802
J34500940
J34500960
J34500962
|
Recalling Firm/ Manufacturer |
Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Dr Rochester NY 14626-5101
|
For Additional Information Contact | Mr. Joe Falvo 585-453-3000 |
Manufacturer Reason for Recall | A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported. |
FDA Determined Cause 2 | Software Design Change |
Action | On January 26, 2024, the firm issued a customer letter to all customers who have V3.8.0 or V3.8.1 installed on their VITROS Analyzer. Customers were informed of the issue and instructed to follow the instructions when using the VITROS System onboard QC package to use the configurable Westgard Rules.
The software will be updated to mitigate this issue 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 | 25 US; 26 OUS |
Distribution | Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Brazil,
Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico,
Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
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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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