Home › Device types › LKQ
Antibody Igm,If, Cytomegalovirus Virus
FDA product code LKQ · Class 2 · Microbiology
12
Registered devices
156
Adverse events
8
Recalls
18
510(k) clearances
Devices with this code
BioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.IMMULITE®/IMMULITE® 1000 Systems CMV IgM — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDBioPlex 2200 — BIO-RAD LABORATORIES, INC.IMMULITE® 2000 Systems CMM CMV IgM — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDBioPlex 2200 — BIO-RAD LABORATORIES, INC.ACCURUN® — Lgc Clinical Diagnostics, Inc.BioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.VIDAS® CMV IgM — BIOMERIEUX SABioPlex 2200 — BIO-RAD LABORATORIES, INC.BioPlex 2200 — BIO-RAD LABORATORIES, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-02-09 | bioMerieux, Inc. | Invalid calibrations (out of range high) while using the product. |
| 2021-03-16 | Biomerieux Inc | bioMerieux received complaints about calibration issue observed on several lots of VIDAS CMV IgM (ref 30205 ; 30205-01). |
| 2016-08-30 | Siemens Healthcare Diagnostics, Inc. | Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay starting |
| 2016-08-30 | Siemens Healthcare Diagnostics, Inc. | Multiple customers reported seeing an increase in imprecision with some patients resulting in high % CVs with the IMMULITE 2000/2000XPi CMV (IgM) assay startin |
| 2013-01-30 | QIAGEN Gaithersburg, Inc. | CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials. |
| 2013-01-30 | QIAGEN Gaithersburg, Inc. | CMV RG PCR kits may contain a mixture of incorrect vials among the correct vials. |
| 2010-09-28 | Quest International, Inc. | Quest International recalled their CMV IgM Test kit because the device failed the test run due to lack of activity in the coated wells. |
| 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 placem |
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