Z-1700-2016Class II

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

Name: Z-1700-2016 1) VITROS Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No...
Creator: Ortho-Clinical Diagnostics
Published: 2016-02-18
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2016-02-18 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of 1) VITROS Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS... on 2016-02-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1700-2016
Classification: Class II
Status: Terminated
Initiated: 2016-02-18
Posted: 2016-05-20
Terminated: 2018-05-30
Recalling firm: Ortho-Clinical Diagnostics, Inc.
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.
Product code: DHA System, Test, Human Chorionic Gonadotropin
Reason for recall: 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)).
FDA root cause: Under Investigation by firm
Action: 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 [email protected] 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.
Quantity in commerce: 14,780 pieces
Distribution: Nationwide Distribution.
Product 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1700-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1700-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-01	2016-05-20

Product code DHA

K063720Class IIVitros Immunodiagnostic Products Total B-Hcg II Reagent Pack, Calibrators, Range VerifiersOrtho-Clinical Diagnostics / cleared 2007-04-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)