ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT(STANDARD MASK)
SEBIA · Model 4819 · UDI-DI 03607360048191
CFF
Prescription
10
510(k) clearances
2
Adverse events
4
Recalls
7
Facilities
Description
ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT (STANDARD MASK)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-09-28 | Kamiya Biomedical Company, LLC | IgA Reagent may start showing cloudiness over time, which can affect assay performance. |
| 2022-04-06 | Helena Laboratories, Corp. | Due to microbial growth causing interference with interpretation. |
| 2017-07-21 | Helena Laboratories, Corp. | The plates do not have wells punched for the controls in the patient 1 area. |
| 2004-01-28 | Beckman Coulter Inc | Inconsistent and incomplete results for IgG. |
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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.