The Recall Desk
HighFDA (Devices)·Z-2624-2023·Announced 2023-09-27

FDA Recalls ALKP Chemistry Analyzer Slides for Potential Diagnostic Errors

Ortho-Clinical Diagnostics is recalling VITROS XT Chemistry ALKP Slides worldwide because high alkaline phosphatase samples may cause the analyzer to report falsely low results, potentially missing or delaying liver disease diagnoses.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device with potential for diagnostic error (false-low results leading to missed diagnosis) but no reported illnesses or injuries to date. This qualifies as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Ortho-Clinical Diagnostics, Inc. is recalling 402,966 units of VITROS XT Chemistry Products ALKP Slides used in the VITROS chemistry analyzer system worldwide. These slides are used to measure alkaline phosphatase (ALKP), an enzyme used to help detect liver disease.

The recalled slides may malfunction when testing samples with high ALKP levels or interfering substances. In these cases, the reagent layer may become depleted, but the system may not signal this depletion. As a result, the analyzer may report an incorrect ALKP value that is lower than the actual value in the sample.

Inaccurate test results could lead to missed or delayed diagnosis of liver disease. The recall affects healthcare facilities and laboratories in the US and over 20 countries including Canada, the United Kingdom, Australia, Japan, Germany, France, and others. Affected lots include Generations 21, 23, 26, 28, 29, and 30, with expiry dates ranging from July 2023 to January 2025.

Healthcare providers should stop using affected product lots and contact Ortho-Clinical Diagnostics for instructions on alternative testing procedures or product replacement.

The recalled product

Product
VITROS XT Chemistry Products ALKP Slides
Manufacturer
Ortho-Clinical Diagnostics, INc.
Category
Medical Device — In Vitro Diagnostic
Hazard
  • incorrect-results
  • missed-diagnosis

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • Product Code: 1053180 UDI:(10758750008346) GEN #21
  • Expiry Date Range 01 Jul 2023 - 01 June 2024 GEN #23
  • Expiry Date Range 01 Oct 2023 - 01 Sep 2024 GEN #26
  • Expiry Date Range 01 Aug 2023 - 01 Dec 2024 GEN #28
  • Expiry Date Range 01 Aug 2024 GEN #29
  • Expiry Date Range 01 Sep 2024 - 01 Dec 2024 GEN #30
  • Expiry Date Range 02 Jan 2025

Distribution

Distributed nationwide across the United States.

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