Home › INSTRUMENTATION LABORATORY COMPANY › HemosIL Factor Diluent
HemosIL Factor Diluent
INSTRUMENTATION LABORATORY COMPANY · Model 00009757600 · UDI-DI 08426950062295
GKP
Prescription
10
510(k) clearances
661
Adverse events (13 deaths)
31
Recalls
17
Facilities
Description
HemosIL Factor Diluent 100 mL
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.