VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296
Reported: September 2, 2020 Initiated: July 13, 2020 #Z-2875-2020
Product Description
VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296
Reason for Recall
Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
Details
- Recalling Firm
- Ortho-Clinical Diagnostics
- Units Affected
- US= 4076 OUS=949
- Distribution
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Belgium, Bermuda HM08, Brazil, Canada L3R 4G5, China, Denmark, France, Germany, Italy, Mexico, Norway, Poland, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
VITROS XT Chemistry Products TBIL-ALKP Slides (ALKP is not affected) In Vitro Diagnostic use only - The TBIL test within the VITROS XT Chemistry Products TBIL-ALKP Slides quantitatively measures total bilirubin (TBIL) concentration in serum and plasma, Product Code: 6844296. Recalled by Ortho-Clinical Diagnostics. Units affected: US= 4076 OUS=949.
Why was this product recalled? ▼
Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 2, 2020. Severity: Moderate. Recall number: Z-2875-2020.
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