Atellica CH A1c_3
Hemoglobin A1c_3 (A1c_3) Atellica CH - RGT 400T
3manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
12recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Wuxi Biohermes BIO & Medical Technology Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 3 |
| Shanghai Medconn Medical Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 2 |
| Shanghai Medconn Biotechnology Co., Ltd. | Jinshan District | Shanghai | Manufacturer | 2 |
Record
| Listed by | Siemens Healthcare Diagnostics Inc, United States |
|---|---|
| FDA product code | LCP |
| Device type | Assay, Glycosylated Hemoglobin |
| Device class | Class 2 |
| Regulation | 21 CFR 864.7470 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2017-12-19 |
| Record revised | 2021-11-18 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2021-07-22 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11097500 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trinity Biotech | Primus Corp. | 36 |
| Variant II Turbo | Bio-Rad Laboratories Inc. | 15 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 11 |
| Variant II Turbo Link | Bio-Rad Laboratories Inc. | 7 |
| D-10 | Bio-Rad Laboratories Inc. | 7 |
| Variant II Hemoglobin A1c | Bio-Rad Laboratories Inc. | 5 |
| Drew Scientific | Drew Scientific, Ltd. | 5 |
| Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 | Tosoh Corp. | 4 |
| D-100 | Bio-Rad Laboratories Inc. | 4 |
| Fructosamine | Roche Diagnostics Gmbh | 4 |
| D-10 Dual | Bio-Rad Laboratories Inc. | 3 |
| JAS Diagnostics | Drew Scientific, Ltd. | 3 |
Showing 12 of 134. All products under Assay, Glycosylated Hemoglobin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131307 | 2014-01-24 |
| K110934 | 2011-08-25 |
| K102510 | 2011-05-13 |
Recalls
12 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2024-02-07 | Class II | Under Investigation by firm | 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 erroneous test results could be reported and potentially lead | 74,211 Kits (Expanded 2/28/24: additional 72,892 kits) | |
| 2022-02-09 | Class II | Device Design | Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. | 199 | |
| 2020-06-30 | Class II | Labeling design | 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 Vantage Analyzer is configured to run Code 39 with check digit and | 1800 units | 2020-11-17 |
| 2020-05-04 | Class II | Device Design | The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples. | 26 | 2021-09-20 |
| 2020-05-04 | Class II | Device Design | The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite of acetaminophen, may cause interference in certain chemistry assays when testing patient samples. | 5 | 2021-09-20 |
| 2016-07-20 | Class II | Software design | Siemens identified an issue with the ratio equation provided on the ADVIA Chemistry XPT System Software Test Definition (TDef) Version 1.0 disks (SMN: 11127343 and 11222123). This issue affects only the ADVIA Chemistry Hemoglobin A1c_3 Aut | Domestic: 32 units; Foreign: 197 units | 2018-06-07 |
| 2015-09-24 | Class II | Under Investigation by firm | Reagent in these lots may demonstrate an increased occurrence of high %HbA1c bias, a positive bias averaging 0.6% HbA1c units, ranging from -0.1% to 1.1% HbA1c units. The maximum bias was observed at higher %HbA1c concentrations. QC samples | 3031 | 2017-01-13 |
| 2014-09-30 | Class II | Nonconforming Material/Component | Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for patient samples when compared to the National Glycohemoglobin Standardization Program (NGSP) | 53, 046 | 2015-08-10 |
| 2014-08-14 | Class II | Device Design | In March, Siemens Healthcare Diagnostics issued an Urgent Medical Device Correction for decreased recovery of patient samples with the Dimension Vista® CSA & CSAE Flex® reagent cartridges when whole blood samples are run from Small Sample C | 20043 | 2015-08-10 |
| 2013-07-30 | Class II | Software design | Siemens confirmed that the ADVIA Chemistry Systems HbA1c method exhibits a positive bias of up to 12% for patient and CAP survey samples due to over-recovery when using A1c_3 Calibrator lots 1MD014, 1BD063, and 2GD014. The established range | US: 1546 units; Foreign: 518 units | 2017-02-28 |
| 2013-04-22 | Class II | Process control | Positive bias on the lots listed compared to alternate methods and a higher frequency of “Above Assay Range” flags with the lots listed. | 11006 Total | 2014-02-12 |
| 2013-04-22 | Class II | Process control | Positive bias on the lots listed compared to alternate methods and a higher frequency of “Above Assay Range” flags with the lots listed. | 11006 Total | 2014-02-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability.
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