Ortho-Clinical Diagnostics: Medical Device Recall in 2016 - (Recall #: Z-1700-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: February 18, 2016

Date Posted: June 1, 2016

Recall Number: Z-1700-2016

Event ID: 73441

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)).

Status: Terminated

Product Quantity: 14,780 pieces

Code Information:

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)

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated