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Immunalysis
IMMUNALYSIS CORP · Model 10057-10 · UDI-DI 00840937111925
DKB
Prescription
10
510(k) clearances
7
Adverse events (1 deaths)
9
Recalls
27
Facilities
Description
Multi-Drug Oral Fluid Calibrator 3
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-10-13 | Ortho-Clinical Diagnostics, Inc. | Calibration disk Data Release Version (DRV) 6194 to 6200 contain inappropriate calibration mathematics for VITROS Calibration Kit 9 for calibrating VITROS PHYT Slides, for all lots |
| 2022-03-08 | MEDLINE INDUSTRIES, LP - Northfield | The product was stored incorrectly due to improper storage controls which may lead to delayed results. |
| 2014-05-12 | Ortho-Clinical Diagnostics | Calibrator values assigned for the calibrator kit lots were released using a reference method that was undergoing validation for a new lot of European Reference Material (ERM). The |
| 2012-12-06 | Siemens Healthcare Diagnostics, Inc. | Incorrect expiration date was assigned to the D1 lot of Emit(R) tox(TM) Serum Calibrators. The correct expiration date is 2013-12-31. The incorrect assigned expiration date is 20 |
| 2011-10-11 | Lin-Zhi International Inc | Catalog # 0804 Multi-Analyte Urine DAU Intermediate Calibrators were incorrectly labeled and mistakenly filled with Catalog # 0805 DAU High Calibrators. |
| 2011-08-23 | Lin-Zhi International Inc | Multi Analyte Urine DAU Cutoff Calibrator Gives a decreased absorbance reading due to a loss of the BZO (oxazepam) analyte from the solution and may cause false positive readings. |
| 2009-08-11 | Beckman Coulter Inc. | The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the lots of Phenobarbital (PHE) reagent and calibrator. |
| 2009-04-22 | Roche Diagnostics Corp. | The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the application of the force required to open the bottles. |
| 2009-04-22 | Roche Diagnostics Corp. | The bottle caps may be more difficult to remove than usual, and minor injuries may be caused by the application of the force required to open the bottles. |
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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.