Z-1556-2013Class II

VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively...

Name: Z-1556-2013 VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively...
Creator: Ortho-Clinical Diagnostics
Published: 2013-04-01
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2013-04-01 / Terminated / root cause: manufacturing process

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in... on 2013-04-01. FDA classified it as Class II and gives the reason as "The firm is recalling the specific lot due to lower than expected results". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1556-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-01
Posted: 2013-06-19
Terminated: 2017-03-22
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: 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 code: LPS Urinary Homocystine (Nonquantitative) Test System
Reason for recall: The firm is recalling the specific lot due to lower than expected results.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Ortho Clinical Diagnostics sent an "Important Product Correction Notification" letter dated April 1, 2013 to all affected customers. Ortho Clinical Diagnostics recommends that their customers immediately discontinue using and discard all VITROS HCY Reagent remaining in your inventory for the affected lot. They have requested that their customers complete and return the attached Confirmation of Receipt form no later than April 12, 2013. Ortho Clinical Diagnostics requested that these notifications be forwarded to all laboratories and posted beside each VITROS System that utilizes VITROS HCY Reagent within their customers facilities. To place a product order for an alternate lot, please contact Ortho Clinical Diagnostics customer service representatives at 1-800-828-6316. The VITROS Chemistry Products HCY Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and the VITROS 5600 Integrated System to quantitatively measure total homocysteine concentration in human serum and plasma.
Quantity in commerce: 478 total (339- Domestic) (139- International)
Distribution: 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.
Product codes and lots: Lot # 1529-17-2636, expiration date 12 June 2013

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1556-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1556-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-26	2013-06-18

Product code LPS

K061588Class IIVitros Chemistry Products Hcy Reagent, Vitros Chemistry Products Calibrator Kit 27, Hcy Performance VerifiersOrtho-Clinical Diagnostics, Inc. / cleared 2006-07-21

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)