Reported Sep 27, 2023 · Ongoing
VITROS XT Chemistry Products TBIL-ALKP Slides
Ortho-Clinical Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics, INc. · 513 Technology Blvd · Rochester, NY · 14626-3601
Is this the product you have?
- VITROS XT Chemistry Products TBIL-ALKP Slides
- Lot codes and dates
5 of 5 products
Products covered by this recall Model / number Barcodes Product as published 684429610758750031801UDI: (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 - Amount recalled
- 52,456 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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