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AccuDiag™
Diagnostic Automation, Inc. · Model DACD 1202-2 · UDI-DI 00894175000558
10
510(k) clearances
309
Adverse events
9
Recalls
29
Facilities
Description
AccuDiag™ Cytomegalovirus IgM ELISA A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to cytomegalovirus (CMV) in a clinical specimen, using an enzyme immunoassay (EIA) method.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2022-10-19 | Bio-Rad Laboratories, Inc. | Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA). |
| 2017-01-11 | BioMerieux SA | During development of the VIDAS 3 software version 1.2, some anomalies have been identified and observed to be already present in the current software version VIDAS 3 version 1.1.4 |
| 2015-03-26 | Diamedix Corporation | Product contained an incorrect substrate. |
| 2009-01-19 | Abbott Laboratories | Defective caps: Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument. |
| 2007-04-23 | Abbott Laboratories | Failure of the AxSYM instrument to open (actuate) some reagent packs from certain lots. The defects can result in probe crashes if not detected prior to placement of the reagent k |
| 2004-06-09 | bioMerieux | The product may give false positive results. |
| 2003-06-18 | Meridian Bioscience Inc | The Low Positive Standard kit component is losing potency that may result in false positive test results. |
| 2003-06-12 | Zeus Scientific Inc | The Calibrator included within the kit may be losing reactivity. |
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