Recall Z-2145-2016— ORTHO-CLINICAL DIAGNOSTICS

Name: FDA recall Z-2145-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-09

Class III · Terminated

Class III FDA medical device recall by ORTHO-CLINICAL DIAGNOSTICS, initiated 2016-05-09, terminated 2018-06-08. It names one FDA 510(k) clearance: K983031. Product: VITROS Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were included in the communication because they are lot-linked to the Reagent Packs and cannot be used with any other lot of reagent. There is no known failure with the Calibrators. For the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the management of patients with non-seminomatous testicular cancer.. Reason: Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the reaction signal over time potentially resulting in the inability to calibrate and use the product..

Recalling firm: ORTHO-CLINICAL DIAGNOSTICS
Classification: Class III
Status: Terminated
Initiated: 2016-05-09
Terminated: 2018-06-08
Firm location: Bridgend, United Kingdom

510(k) clearances named in this recall

1 on FDA's record

K983031 — VITROS IMMUNODIAGNOSTIC PRODUCTS AFP ASSAYOrtho-Clinical Diagnostics, Inc.·cleared 1998-12-18

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 Immunodiagnostic Products AFP Reagent Pack, REF/Product Code 680 0784, Unique Device Identifier No. 10758750000876, IVD; --- Ortho-Clinical Diagnostics Percoed, Bridgend, UK --- Please note: the VITROS Immunodiagnostic Products AFP Calibrators, Unique Device Identifier No. 10758750000913, REF 680 0863, were included in the communication because they are lot-linked to the Reagent Packs and cannot be used with any other lot of reagent. There is no known failure with the Calibrators. For the quantitative measurement of alpha-fetoprotein (AFP) concentrations in human serum using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the management of patients with non-seminomatous testicular cancer.

Reason for recall

Ortho Clinical Diagnostics (OCD) confirmed that specific lots of VITROS Immunodiagnostic Products AFP Reagent Pack product exhibit an increase in the reaction signal over time potentially resulting in the inability to calibrate and use the product.

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