Z-0569-2014Class II

IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number...

Name: Z-0569-2014 IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number...
Creator: Siemens Healthcare Diagnostics
Published: 2013-11-06
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2013-11-06 / Terminated / root cause: labeling and UDI

FDA source

Siemens Healthcare Diagnostics began a recall of IMMULITE/IMMULITE 1000 Systems FOL Folic Acid, REF/Catalog Number LKFO1 (100 tests), Siemens Material Number (SMN) 10380902, IVD; for in vitro diagnostic use... on 2013-11-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0569-2014
Classification: Class II
Status: Terminated
Initiated: 2013-11-06
Posted: 2013-12-24
Terminated: 2017-03-23
Recalling firm: Siemens Healthcare Diagnostics Inc.
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.
Product code: CGN Acid, Folic, Radioimmunoassay
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.
Root cause tag: labeling and UDI
FDA root cause: Unknown/Undetermined by firm
Action: Siemens sent an Urgent Medical Device Correction notices dated November 7 2013, via FedEx to the US customers. The letter identified the product the problem and the action needed to be taken by the customers. Customers are instructed that If the adjustment slope is less than or equal to 1.8 and quality control results are within the established ranges, the kit may be used to generate patient results. If the adjustment slope is greater than 1.8, customers are instructed to discontinue use and discard the kit lots. Ex-US distribution is determined at the country level. Customers are requested to complete and return the Effectiveness Check questionnaire attached to the Urgent Medical Device Correction letter within thirty (30) days. Field service personnel were sent a support document describing the issue and instructing them how to deal with customer questions. For further questions please call CUSTOMER CARE CENTER NUMBER: (302) 631-7597.
Quantity in commerce: Domestic: 442 kits; Foreign: 680 kits
Distribution: Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of Argentina, Bosnia-Herzegovina, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Denmark, Dominican Republic, Estonia, France, Germany, Great Britain, Greece, Guatemala, Hungary, India, Italy, Latvia, Mexico, Netherlands, Panama, Paraguay, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Tunisia, United Arab Emirates, Uzbekistan and Venezuela.
Product codes and lots: Kit Lots 335, 336, and 337

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0569-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0569-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-01	2013-12-24

Product code CGN

K943705Class IIFolic AcidDiagnostic Products Corp. / cleared 1994-10-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)