Home › Device types › LKJ
Antinuclear Antibody, Antigen, Control
FDA product code LKJ · Class 2 · Immunology
81
Registered devices
23
Adverse events
13
Recalls
50
510(k) clearances
Devices with this code
BioPlex 2200 — BIO-RAD LABORATORIES, INC.Liquichek — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.SeraQuest — QUEST INTERNATIONAL, INC.EliA Ro60 Well — Phadia ABIMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.EliA La Well — Phadia ABReQuest — QUEST INTERNATIONAL, INC.Autoimmune EIA — BIO-RAD LABORATORIES, INC.Trinity Biotech — CLARK LABORATORIES, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.Autoimmune EIA — BIO-RAD LABORATORIES, INC.DIASTAT ANA — Svar Life Science ABImmco Diagnostics, Inc. — IMMCO DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.Liquichek — BIO-RAD LABORATORIES, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.IMMCO DIAGNOSTICS — IMMCO DIAGNOSTICS, INC.
Recent 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 s |
| 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 pote |
| 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 |
| 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 |
| 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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.