Ortho-Clinical Diagnostics: Medical Device Recall in 2013 - (Recall #: Z-1556-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.

Product Classification:

Class II

Date Initiated: April 1, 2013

Date Posted: June 26, 2013

Recall Number: Z-1556-2013

Event ID: 64874

Reason for Recall:

The firm is recalling the specific lot due to lower than expected results.

Status: Terminated

Product Quantity: 478 total (339- Domestic) (139- International)

Code Information:

Lot # 1529-17-2636, expiration date 12 June 2013

Distribution Pattern:

Worldwide Distribution-USA (nationwide) including the states of AR, AZ, CA, CO, CT, FL, HI, ID, IL, KY, LA, ME, NJ, OK, TN, TX, WA, and WV, and the countries of Colombia, India, Japan, Mexico, Puerto Rico, Republic of Panama, Singapore, Venezuela, England, France, Germany, Italy, and Spain.

Voluntary or Mandated:

Voluntary: Firm initiated