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Dimension Vista® Flex® reagent cartridge E2
Siemens Healthcare Diagnostics Inc. · Model 10489099 · UDI-DI 00842768026461
1
510(k) clearances
27
Adverse events
3
Recalls
7
Facilities
Description
LOCI Estradiol Flex® reagent cartridge, 320 Tests
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-12-21 | Beckman Coulter Inc. | The recall was initiated because the lots of Inhibin A identified above may contain microbial contamination in the conjugate diluent bottles included in the kit. |
| 2010-12-21 | Beckman Coulter Inc. | The recall was initiated because the lots of Inhibin A identified above may contain microbial contamination in the conjugate diluent bottles included in the kit. |
| 2010-11-10 | Beckman Coulter Inc. | The recall was initiated because Beckman Coulter has confirmed the microbial contamination in the conjugate diluent bottles included in the Manual Inhibin A Elisa kit (Part Number |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.