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IMMCO DIAGNOSTICS
IMMCO DIAGNOSTICS, INC. · Model 1103-210 · UDI-DI 00845714002007
LKJ
Prescription
1
510(k) clearances
23
Adverse events
13
Recalls
15
Facilities
Description
Hep-2 Cells -Anti-Nuclear Antibody IFA Kit
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-11-01 | Bio-Rad Laboratories, Inc. | A new lot of ANA screen control and any subsequent control lots are incompatible with older lot numbers of ANA calibrators and ANA reagent packs. |
| 2017-05-22 | Euro Diagnostica AB | FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit box of the lot informed customers that the shelf-life had been shortened and referen |
| 2017-02-14 | Euro Diagnostica AB | Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false |
| 2016-10-21 | Euro Diagnostica AB | Incorrectly labeled Manufactured by DiaSorin, The correct term should be Distributed by DiaSorin. |
| 2015-10-15 | Euro Diagnostica AB | Complaint investigation concluded that although product quality requirements stated in the instructions for use were met at lot release, the high background in the ELISA plate, the |
| 2010-06-24 | Bio-Rad Laboratories Inc | Product mislabeled-- the ANA cutoff Control and Prostiva controls were mislabeled. Use of the incorrect controls will cause run failure - patient results cannot be reported because |
| 2010-03-01 | Bio-Rad Laboratories Inc | The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading. |
| 2010-03-01 | Bio-Rad Laboratories Inc | The firm received customer complaints of increased positivity rates associated with the ANA Screening kit due to a decline in stability. |
| 2010-03-01 | Bio-Rad Laboratories Inc | Inaccurate results-- Consumer complaints of increased positivity rates with the ANA screening kit. |
| 2010-03-01 | Bio-Rad Laboratories Inc | The ANA Screening kit generates a high percentage of false positive results, associated with a low check control reading. |
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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.