PlainRecordsFDA · Medical device recall
VITROS Performance Verifier I and 1 more product
- Date
- April 3, 2024
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing
- Filed by
- Ortho-Clinical Diagnostics
- Reason
- 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.
- 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.
2 products in this recall
VITROS Performance Verifier I
- Product
- VITROS Performance Verifier I
- Quantity
- 10,911 units
- Codes and lots
- Product Code: 8067324; GTIN: 10758750004317; Lot No. Q1174.
- Recall started
- Feb. 27, 2024
- Device type
- Multi-Analyte Controls, All Kinds (Assayed)
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- 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.
- Recall number
- Z-1372-2024
VITROS Performance Verifier II
- Product
- VITROS Performance Verifier II
- Quantity
- 11,224 units
- Codes and lots
- Product Code: 8231474; GTIN: 10758750004577; Lot No. R1176.
- Recall started
- Feb. 27, 2024
- Device type
- Multi-Analyte Controls, All Kinds (Assayed)
- Root cause (FDA)
- Under Investigation by firm
- What the company told customers
- 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.
- Recall number
- Z-1373-2024
What should I do? How serious is a recall? Classes and warnings explained
Source: FDA · Medical device enforcement reports, recall numbers Z-1372-2024, Z-1373-2024. The agency record governs; check it and the company before acting.