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BioPlex 2200

BIO-RAD LABORATORIES, INC. · Model SW4_V3 · UDI-DI 00847865003179

LKQ LFX LFZ

510(k) clearances

156

Adverse events

Recalls

Facilities

Description

Manual & CDs, Rubella & CMV IgM IFU, SW4_v3, US Only

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 with reagent lots 2
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 with reagent lots
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 placement of the reagent k

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Data 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.