Recall Z-2873-2020— Ortho-Clinical Diagnostics

Name: FDA recall Z-2873-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-13

Class II · Terminated

Class II FDA medical device recall by Ortho-Clinical Diagnostics, initiated 2020-07-13, terminated 2021-07-27. It names one FDA 510(k) clearance: K182063. Product: VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931. Reason: Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides.

Recalling firm: Ortho-Clinical Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2020-07-13
Terminated: 2021-07-27
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K182063 — VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated SystemOrtho-Clinical Diagnostics, Inc.·cleared 2018-10-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

VITROS Chemistry Products TBIL Slides- 5 PACK/300 SLDS In vitro Diagnostic quantitatively measure total bilirubin (TBIL) concentration in serum and plasma, Product code: 8159931

Reason for recall

Etrombopag Interference for VITROS Chemistry Products: TBIL Slides, VITROS BuBc Slides and VITROS XT TBIL-ALKP Slides

Data sourced from openFDA. This site is unofficial and independent of the FDA.