Siemens Healthcare Diagnostics, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1227-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Product Classification:

Class II

Date Initiated: January 11, 2017

Date Posted: March 1, 2017

Recall Number: Z-1227-2017

Event ID: 76251

Reason for Recall:

The firm confirmed a reduced once-opened and on-board stability for N Latex Homocysteine (HCY) OPAX03 lot 802907632 that may result in erroneously reduced or elevated homocysteine values. The stability issue may lead to higher than expected lot-to-lot variation and an impaired product performance.

Status: Terminated

Product Quantity: US: 62 kits; Foreign: 290 kits

Code Information:

Lot 802907632, Exp. 2017-02-13

Distribution Pattern:

Worldwide Distribution - US Nationwide in the state of Colorado and Foreign distribution to the following countries: Austria, Brazil, Canary Islands, Chile, China, Czech Republic, France, Germany, Great Britain (UK), Italy, Kuwait, Latvia, Poland, Saudi Arabia, Spain, Switzerland, Turkey, United Arab Emirates.

Voluntary or Mandated:

Voluntary: Firm initiated