Z-1227-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- March 1, 2017
- Initiation Date
- January 11, 2017
- Termination Date
- June 12, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 62 kits; Foreign: 290 kits
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.
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.
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.
Code Information
Lot 802907632, Exp. 2017-02-13