Home › SYSMEX CORPORATION › CA CAL S
CA CAL S
SYSMEX CORPORATION · Model 014-1271-4 · UDI-DI 04987562516797
GKP
Prescription
10
510(k) clearances
661
Adverse events (13 deaths)
31
Recalls
18
Facilities
Description
The product is applied to calibrate the sensitivity of LEDs used for blood coagulation analyzer.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-07-13 | Instrumentation Laboratory | Sample misidentification could occur under specific conditions and patient management altered based on an incorrectly assigned result |
| 2022-02-22 | Instrumentation Laboratory | Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when Hemo |
| 2014-06-03 | Instrumentation Laboratory Co. | Potential for sample misidentification. |
| 2014-06-03 | Instrumentation Laboratory Co. | Potential for sample misidentification. |
| 2014-06-03 | Instrumentation Laboratory Co. | Potential for sample misidentification. |
| 2014-06-03 | Instrumentation Laboratory Co. | Potential for sample misidentification. |
| 2014-06-03 | Instrumentation Laboratory Co. | Potential for sample misidentification. |
| 2014-06-03 | Instrumentation Laboratory Co. | Potential for sample misidentification. |
| 2014-06-03 | Instrumentation Laboratory Co. | Potential for sample misidentification. |
| 2013-07-19 | Instrumentation Laboratory Co. | Potential carryover issue that can can cause shortened APTT clotting times on the instrument. |
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.