Recall Z-1227-2017— Siemens Healthcare Diagnostics, Inc.

Name: FDA recall Z-1227-2017
Creator: U.S. Food and Drug Administration
Published: 2017-01-11

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2017-01-11, terminated 2018-06-12. It names one FDA 510(k) clearance: K052788. 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.. Reason: 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..

Recalling firm: Siemens Healthcare Diagnostics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-01-11
Terminated: 2018-06-12
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K052788 — N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/HDade Behring, Inc.·cleared 2006-03-29

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.