IMMULITE/IMMULITE 1000 Systems FOL Folic Acid — Class II medical device recall Z-0569-2014
Terminated recall by Siemens Healthcare Diagnostics, reported 2014-01-01, distributed nationwide. potential for an accelerated decline in counts per second (CPS) for three IMMULITE/IMMULITE 1000 Folic Acid ki
| Recall number | Z-0569-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Healthcare Diagnostics, Tarrytown, NY, United States |
| Recall initiated | 2013-11-06 |
| Classified | 2013-12-24 |
| Reported by FDA | 2014-01-01 |
| Terminated | 2017-03-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, BG, BR, CA, CL, CN, CO, CR, CY, DE, DK, DO, EE, ES, FR, GB, GR, GT, HU, IN, IT, LV, MX, NL, PA, PL, PT, PY, QA, RO, RS, SA, SG, SK, TN, VE, ZA |
| Reason classes | labeling |
| Lot numbers | 335, 336, 337 |
| Model numbers | LKFO1 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0569-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.