Ortho-Clinical Diagnostics: VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (heparin, EDTA or citrate). The performance of the VITROS Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assay.

Recall number

Z-0313-2017

Recalling firm

Ortho-Clinical Diagnostics

Product

VITROS Immunodiagnostic Products HBsAg Controls, Product Code 6800598 For in vitro diagnostic use only. For use in monitoring the performance of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System when used for the in vitro qualitative detection of Hepatitis B Surface Antigen (HBsAg) in human serum and plasma (heparin, EDTA or citrate). The performance of the VITROS Immunodiagnostic Products HBsAg Controls has not been established with any other HBsAg assay.

Status

Terminated

Initiated

2016-06-22

Posted

not on file

Terminated

2018-06-11

Reason

The signal/cutoff (s/c) results may increase throughout the open-reconstituted timeframe of the allowed 5 days. Increased results may occur on both the negative and positive Controls. The positive Control, although showing elevated results, was still within acceptable performance.

Root cause

Under Investigation by firm

Action

The firm, Ortho Clinical Diagnostics, distributed "Important Product Correction Notification" letters (Ref. CL2016-129) dated 6/22/2016 and Confirmation of Receipts to their customers via FedEx overnight courier and/ or ORTHO PLUS e-Communications and/ or US Postal Service Priority Mail (for PO Boxes only). Foreign affiliates were informed by email (on 22 June 2016) of the issue and instructed to notify their consignees of the issue and required actions. All customers who received the affected product were instructed to immediately discontinue using and discard the affected lots. Forward a copy of the notification if you have provided the affected lot(s) outside of your facility. Post a copy of the notification by each VITROS System that processes VITROS HBsAg Controls and Complete and return the Confirmation of Receipt-Response Required form via fax to: 1.888.557.3759 or 1.585.453.4110 or scan to PDF and email to: RA-OCDUS-CONFIRMAD@ORTHOCLINICALDIAGNOSTICS.COM no later 7/1/2016. (Note: If you DO NOT have an alternate lot, it is acceptable to continue using the affected lot(s) following these instructions: 1) Control results must be within acceptable limits on the day of reconstitution (Day 1). 2) Store open-reconstituted vials frozen for up to 4 weeks. The firm recommends that customers aliquot the open-reconstituted material prior to freezing so that multiple aliquots of the same vial can be used. 3) Upon receipt of your replacement order, discard all remaining inventory. Customers with questions please call the Ortho Technical Solutions Center at 1-800-421-3311.

Quantity

1,621 units

Distribution

Worldwide Distribution-USA (nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, Spain and Poland.

Lot, serial or model codes

Product Code 6800598-Lot #'s: 1) 0860, 2) 0870, 3) 0880, 4) 0890, 5) 0908 Expiration: 1) 29-MAR-17, 2) 12-JUN-17, 3) 02-JUL-17, 4) 23-NOV-17, 5) 29-JAN-18

510(k) numbers

["K030067"]

PMA numbers

not on file

Product code

MJX

Firm FEI

1000136573

Firm city

Rochester

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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