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ELECTRACHROME Factor VIII
INSTRUMENTATION LABORATORY COMPANY · Model 049730503 · UDI-DI 08426950101697
GGP
Prescription
1
510(k) clearances
23
Adverse events
14
Recalls
21
Facilities
Description
ELECTRACHROME Factor VIII
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-29 | Diagnostica Stago, Inc. | A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified |
| 2026-02-04 | Diagnostica Stago, Inc. | The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values. |
| 2023-02-01 | Aniara Diagnostica LLC | New warnings and precautionary statements on product labelling: Reagent 2 (R2) of BIOPHEN Protein C 5 contains the chemical substance - Cesium Chloride which changed classification |
| 2020-03-04 | Diagnostica Stago, Inc. | A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause factor VIII levels report |
| 2017-04-04 | Helena Laboratories, Inc. | Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Protein S Conjugate Solution is labeled as Substrate, and the Substrate is labeled as |
| 2015-12-18 | Instrumentation Laboratory Co. | This Lot is not meeting labeled on-board instrument stability claims of 5 days. |
| 2015-11-19 | Siemens Healthcare Diagnostics, Inc. | Factor VIII Chromogenic Assay Lot 44637 is showing an increased occurrence of irregular curves when used for measurement on Sysmex CA-1500, CA-7000, CS-2000i, CS-2100i, CS-5100 Sys |
| 2012-10-24 | Sekisui Diagnostics Llc | Spectrolyse PAI-1 activity assay, producing lower than expected absorbance values 0 IU/ml standard reducing the slope of the standard curve requiring more frequent sample dilutio |
| 2012-08-28 | Sekisui Diagnostics Llc | SPECTROLYSE PAI-1 activity assay producing lower than expected absorbance values with "0" standard. This will reduce the slope of the standard curve requiring the user to make mor |
| 2012-04-11 | Instrumentation Laboratory Co. | Falsely elevated levels may be reported with the HemosIL von Willebrand Factor Activity assay. |
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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.