Home › Siemens Healthcare Diagnostics Products GmbH › N FLC Control SL2
N FLC Control SL2
Siemens Healthcare Diagnostics Products GmbH · Model 10482442 · UDI-DI 00842768031465
1
510(k) clearances
58
Adverse events
2
Recalls
18
Facilities
Description
Assayed accuracy and precision controls in the determination of free light chains (FLC) type kappa and type lambda on Siemens analyzers
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-05-20 | The Binding Site Group, Ltd. | The high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values. |
| 2020-11-18 | The Binding Site Group, Ltd. | Due to customer complaints of positive bias impacting quality control. The high and low level controls are demonstrating a positive bias compared to assigned values. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.