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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products Performance Verifier

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 Class 2 Device Recall VITROS Chemistry Products Performance Verifiersee related information
Date Initiated by FirmFebruary 27, 2024
Date PostedMarch 22, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1373-2024
Recall Event ID 94174
Product Classification Multi-analyte controls, all kinds (assayed) - Product Code JJY
ProductVITROS Performance Verifier II
Code Information Product Code: 8231474; GTIN: 10758750004577; Lot No. R1176.
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics
1000 Lee Rd
Rochester NY 14606-4250
For Additional Information ContactJoe Falvo
585-453-3452
Manufacturer Reason
for Recall		The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.
FDA Determined
Cause 2		Under Investigation by firm
ActionConsignees were sent an URGENT PRODUCT CORRECTION NOTIFICATION dated 2/27/24 informing them that for product Lot Q1174, diluent Lot M9815 was found in some sales units instead of the expected diluent Lot Q1175, and for product Lot R1176, diluent Lot P9967 was found in some sales units instead of the expected diluent Lot R1177. Consignees were asked to inspect their inventory to see if any mismatched product from affected lots was present and to discard any affected units. The provided Confirmation of Receipt form is to be returned by 3/8/24. Results received using affected devices are to be reviewed for any unexpected QC shift. The recall notification is to be forwarded if any devices were further distributed and the notification maintained in the User Documentation. Customers with any questions can call Global Services at 1-800-421-3311.
Quantity in Commerce11,224 units
DistributionWorldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
Total Product Life CycleTPLC Device Report
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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