Recall Z-0569-2014— Siemens Healthcare Diagnostics

Name: FDA recall Z-0569-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-06

Class II · Terminated

Class II FDA medical device recall by Siemens Healthcare Diagnostics, initiated 2013-11-06, terminated 2017-03-23. It names one FDA 510(k) clearance: K943705. Product: IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- Siemens Healthcare Diagnostics Products Ltd. An IVD for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.. Reason: potential for an accelerated decline in counts per second (CPS) for three IMMULITE/IMMULITE 1000 Folic Acid kit lots. This may lead to a failed adjustment before the labeled expiration date is reached..

Recalling firm: Siemens Healthcare Diagnostics
Classification: Class II
Status: Terminated
Initiated: 2013-11-06
Terminated: 2017-03-23
Firm location: Tarrytown, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K943705 — FOLIC ACIDDiagnostic Products Corp.·cleared 1994-10-31

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

IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers --- Siemens Healthcare Diagnostics Products Ltd. An IVD for the quantitative measurement of folic acid in serum, heparinized plasma or ascorbic acid-treated whole blood, as an aid in clinical diagnosis and treatment of anemia.

Reason for recall

potential for an accelerated decline in counts per second (CPS) for three IMMULITE/IMMULITE 1000 Folic Acid kit lots. This may lead to a failed adjustment before the labeled expiration date is reached.

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