Summary
The FDA issued a Class II for VITROS XT Chemistry Products TBIL-ALKP Slides by Ortho-Clinical Diagnostics, INc.. Reason: Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide.
Details
Source
Device Recall
External ID
Z-2623-2023
Action Date
2023-09-27
Status
Ongoing
Category
device
Product Description
VITROS XT Chemistry Products TBIL-ALKP Slides
Lot/Code Info: Product Code: 6844296 UDI: (10758750031801) GEN #16; Expiry Date Range 01 Jul 2023 - 01 Sep 2023 GEN #17; Expiry Date Range 01 Nov 2023 - 01 Feb 2024 GEN #18; Expiry Date Range 01 Apr 2024 - 01 Aug 2024 GEN #19; Expiry Date Range 01 Aug 2024 - 01 Jan 2025
Quantity Affected: 52,456 units
Reason for Recall
Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.
Distribution
Worldwide Distribution: US (nationwide) and OUS (foreign) distribution to countries of: Bermuda, Belgium, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, Italy, India, Japan, Mexico, Netherlands, Norway, Singapore, Spain, Sweden, Portugal, Russia, United Kingdom
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-05
Company
Rochester, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 195 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ortho-Clinical Diagnostics, INc. has 71 FDA actions in our database, including 67 recalls and 4 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ortho-Clinical Diagnostics, INc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ortho-Clinical Diagnostics, INc. have FDA actions?
Ortho-Clinical Diagnostics, INc. has 71 FDA actions in our database, including 67 recalls and 4 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2623-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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