VITROS XT Chemistry Products TBIL-ALKP Slides
Reported: September 27, 2023 Initiated: August 5, 2023 #Z-2623-2023
Product Description
VITROS XT Chemistry Products TBIL-ALKP Slides
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.
Details
- Recalling Firm
- Ortho-Clinical Diagnostics, INc.
- Units Affected
- 52,456 units
- 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
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
VITROS XT Chemistry Products TBIL-ALKP Slides. Recalled by Ortho-Clinical Diagnostics, INc.. Units affected: 52,456 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 27, 2023. Severity: Moderate. Recall number: Z-2623-2023.
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