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Siemens Healthcare Diagnostics, Inc. recalls N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the qu
Recalled March 1, 2017 · FDA recall Z-1227-2017 · Siemens Healthcare Diagnostics
Hazard
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. · FDA Class II
Units
US: 62 kits; Foreign: 290 kits
Sold at
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.
Description
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.
Product
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.
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →