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Alinity-Architect
ABBOTT LABORATORIES · Model 01P0603 · UDI-DI 00380740168209
9
510(k) clearances
327
Adverse events
12
Recalls
13
Facilities
Description
Transplant Pretreatment Tubes
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-07 | Siemens Healthcare Diagnostics, Inc. | A potential positive bias in quality control (QC) and patient sample results in three lots of the Dimension Tacrolimus (TAC) Flex reagent cartridge. |
| 2023-01-30 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthineers has received customer complaints and confirmed imprecision for Quality Control (QC) and patient samples with Dimension Tacrolimus (TAC) lots GA2286, GA3047 and |
| 2022-01-20 | Microgenics Corporation | Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacr |
| 2017-06-29 | Siemens Healthcare Diagnostics, Inc. | Various assays used to measure different chemical levels in blood, urine, or cerebrospinal fluid may interfere with the drugs sulfasalazine and/or sulfapyridine causing falsely ele |
| 2015-03-16 | Diasorin Inc. | Instability in the PRO-Trac II Tacrolimus ELISA kit which may cause falsely elevated patient results. |
| 2013-07-01 | Siemens Healthcare Diagnostics, Inc. | Siemens initiated a recall due to confirmed complaints of low patient sample recovery with Dimension TACR Flex Reagent cartridge (DF107) lot BB4087 and its linked calibrator (DC 10 |
| 2013-04-25 | Siemens Healthcare Diagnostics, Inc. | Siemens has confirmed that the TACR method may demonstrate reduced on-board stability which may result in imprecise and inaccurate QC and patient results. |
| 2012-11-27 | Siemens Healthcare Diagnostics, Inc. | Siemens has confirmed customer complaints of low patient sample recovery with Dimension(R) TACR Flex(R) lot FA3085. Quality Control (QC) materials have not exhibited low recover |
| 2010-09-07 | Abbott Laboratories | There are reagent barcode read errors when using reagent lot 86599M500 due to the print quality of the barcode. |
| 2010-06-15 | Siemens Healthcare Diagnostics, Inc. | Low patient sample recovery results in all affected lots, with possibility of inappropriate increase in tacrolimus dosage based on false low result. |
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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.