1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No…

Date

June 1, 2016

Risk class

Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)

Status

Terminated

Filed by

Ortho-Clinical Diagnostics

Product

1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS¿ Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Identifier No. 10758750002337, 20758750002334); For quantitative measurement of human chorionic gonadotropin (hCG) and its beta subunit in human serum and plasma.

Reason

When testing was conducted using certain lots, VITROS¿ Systems generated results within the measuring range for samples known to not contain measurable hCG. The system reported results up to approximately 7.40 mIU/mL (IU/L) for patient samples that should have been less than the measuring range of the assay (<2.39 mIU/mL (IU/L)).

Distribution pattern

Nationwide Distribution.

Quantity

14,780 pieces

Codes and lots

Product Codes: 6802220, 6802221; Affected Lot Numbers: 1410, 1420, 1430 (With Expiry Date 17-Jun-2016), Lot Number: 1440 (With Expiry Date 15-Aug-2016, Lot Numbers: 1450, 1460, 1470 (With Expiry Date 17-Aug-2016) and Lot Number 1480 distributed only outside of U.S. (With Expiry Date 30-Sept-2016)

Recall started

Feb. 18, 2016

Device type

System, Test, Human Chorionic Gonadotropin

Root cause (FDA)

Under Investigation by firm

What the company told customers

On February 18, 2016, Ortho Clinical Diagnostics distributed Urgent Product Correction Notification letters and Confirmation of Receipt Forms to their customers (Ref. CL2016-043) via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail. Customers are advised to immediately discontinue using and discard all remaining inventory of the listed lots. Ortho Clinical Diagnostics will replace all remaining inventory or provide account credits as indicated on the confirmation of receipt form. Customers are advised to review previously reported results using the affected lots and to discuss these findings with your Laboratory Medical Director to determine the appropriate course of action. Post the notification by your VITROS System or with your user documentation. Complete and return the Confirmation of Receipt form to Joe Falvo via email at confirmationadmin@its.jnj.com or by fax to 1-888-557-3759 or to 1-585-453-4110. Clients with questions can contact Customer Technical Services at 1-800-421-3311 at any time.

Recall number

Z-1700-2016

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-1700-2016. The agency record governs; check it and the company before acting.