FDA Device recall Z-0046-2013
Access Folate Calibrators, Part Number: A14207
- FDA Device
- Class II
- terminated
- Published 2012-10-17
On 2012-10-17 the FDA classified a Class II recall of Access Folate Calibrators, Part Number: A14207 by Beckman Coulter, citing beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0046-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-24 |
| Published | 2012-10-17 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Beckman Coulter |
| Distribution | US |
Product
Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems.
Reason
Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency.
Identifiers
| code_info | Lot# 112788, 115741, 118917 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0046-2013%22
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