Phadia 5000E
Phadia AB · Model 12-4000-01 · UDI-DI 07333066020907
NHX
Prescription
10
510(k) clearances
44
Adverse events
9
Recalls
23
Facilities
Description
Phadia 5000E
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur |
| 2023-02-21 | Bio-Rad Laboratories, Inc. | Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot v |
| 2023-02-21 | Bio-Rad Laboratories, Inc. | Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot v |
| 2019-08-14 | Siemens Healthcare Diagnostics, Inc | Atellica IM anti-CCP IgG (aCCP) Test Definition (TDef) Mitigation Failure-reagent carryover mitigation for the Testosterone II (TSTII) assay is unable to be completed as defined in |
| 2019-07-16 | Roche Diagnostics Operations, Inc. | Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma sa |
| 2019-07-16 | Roche Diagnostics Operations, Inc. | Performance issues with certain lots of the Elecsys Anti-CCP assay on the cobas e 411 analyzer; MODULAR ANALYTICS E 170 module; and cobas e 601, 602, and 801 modules with plasma sa |
| 2017-01-30 | Phadia US Inc | Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles. Investigation showed problems wi |
| 2016-02-14 | Euro Diagnostica AB | Decreasing performance overtime. |
| 2005-11-11 | Axis-Shield Diagnostics, Ltd. | The preservative sodium azide used in the Kit Negative Control (part number FCOM175) was at the wrong concentration - the Kit Negative Control contains 0.2% sodium azide rather tha |
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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.