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ARCHITECT

ABBOTT IRELAND · Model 04T0420 · UDI-DI 00380740180720

CHI Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

Lipase2

Recalls

Date	Firm	Reason
2023-09-12	Ortho-Clinical Diagnostics, INc.	Products 1668409 and 8297749 may contain VITROS Lipase Slides with an abnormality which could cause -46% to +86% bias in lipase results depending on how the slides are used. Falsel
2020-06-26	RANDOX LABORATORIES, LTD.	Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches.
2020-06-26	RANDOX LABORATORIES, LTD.	Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase R2 Substrate batches.
2020-06-26	RANDOX LABORATORIES, LTD.	Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase reagent batches.
2019-12-20	Siemens Healthcare Diagnostics, Inc.	Firm has received customer complaints regarding failed calibrations and increased imprecision of quality control and patient samples when using this product.
2019-02-06	Medica Corporation	Wash1 solution is ineffective in cleaning dispensing probe of TRIG and LDL reagents that interfere with the Lipase (LIP) assay on the EasyRA clinical chemistry analyzer.
2018-10-30	Horiba Instruments Incorporated	Potential for chemical analyzer to report abnormal results due to an interference with triglycerides CP and Cholesterol CP. An over estimation of the lipase concentration could b
2018-09-07	Siemens Healthcare Diagnostics, Inc.	There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
2018-09-07	Siemens Healthcare Diagnostics, Inc.	There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
2017-12-14	Siemens Healthcare Diagnostics, Inc.	Calibration failure - confirmed a positive bias with LIPL lot FB8109 when compared to other Dimension LIPL lots. Lot FB8109 is not meeting Siemens internal specifications for lot-t

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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.