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TRUE+ A1CNow Self Check
POLYMER TECHNOLOGY SYSTEMS, INC. · Model 3075 · UDI-DI 00021292015022
1
510(k) clearances
2,943
Adverse events
103
Recalls
66
Facilities
Description
The A1CNOW® Self Check Test System provides quantitative measurement of the percent of glycated hemoglobin (%HbA1C or %A1C) levels in human whole blood samples.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | GET TESTED INTERNATIONAL AB | Distribution without premarket approval/clearance. |
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur |
| 2024-09-18 | Polymer Technology Systems, Inc. dba PTS Diagnostics, Inc. | The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analy |
| 2024-06-17 | Abbott Diagnostics Technologies AS | Five Afinion 2 (AF2) Analyzer were incorrectly market configured as Moderate Complexity and distributed to customers. Use of moderately complex assays by waived laboratories could |
| 2024-02-07 | Siemens Healthcare Diagnostics, Inc. | The reason for the recall is that the Siemens DCA HbA1c Reagent Kit was confirmed to display a positive bias without alerting the user. The potential impact of the defect is that e |
| 2022-02-09 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. |
| 2020-06-30 | Siemens Healthcare Diagnostics, Inc. | If DCA Vantage Analyzer is configured to run Code 39 with check digit, the scanner is not confirming the integrity of read barcode data using the check digit. Also, if DCA Vantag |
| 2020-05-04 | Siemens Healthcare Diagnostics, Inc. | The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples. |
| 2020-05-04 | Siemens Healthcare Diagnostics, Inc. | The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples. |
| 2018-10-05 | Tosoh Bioscience Inc | Tosoh Bioscience has become aware of potential degradation of HbA1c control lot # 7055 before the 60-days product stability claim. If degradation of these controls occurs, P00 pea |
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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.