—#206519

Product

VITROS Performance Verifier II

FDA product code: JJY — Multi-Analyte Controls, All Kinds (Assayed)
Device class: Class 1
Medical specialty: Clinical Chemistry
Affected lot / code info: Product Code: 8231474; GTIN: 10758750004577; Lot No. R1176.

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Consignees 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.

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 1000 Lee Rd, Rochester, New York 14606-4250

Distribution

Distribution pattern: Worldwide 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.

Timeline

Recall initiated: 2024-02-27
Posted by FDA: 2024-03-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206519. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.