Access Thyroglobulin Antibody II Calibrators
The Access Thyroglobulin Antibody II (TgAb) Calibrators are intended to calibrate the Access Thyroglobulin Antibody II assay for the quantitative determination of thyroglobulin antibody…
The Access Thyroglobulin Antibody II (TgAb) Calibrators are intended to calibrate the Access Thyroglobulin Antibody II assay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access Immunoassay Systems.
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 4 |
Record
| Listed by | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | JIT |
| Device type | Calibrator, Secondary |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1150 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Record published | 2016-09-09 |
| Record revised | 2018-04-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A36920 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vitros | Ortho-Clinical Diagnostics, Inc. | 39 |
| Exact Diagnostics | Exact Diagnostics | 30 |
| Architect | Abbott Medical | 26 |
| Architect | Abbott Ireland | 24 |
| Alinity | Abbott Medical | 18 |
| Alinity | Abbott Ireland | 16 |
| Architect | Abbott Laboratories | 15 |
| Architect | Abbott Ireland Diagnostics | 11 |
| Alinity | Abbott Ireland Diagnostics | 11 |
| JAS Diagnostics | Drew Scientific, Ltd. | 10 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 8 |
| AU | Beckman Coulter, Inc. | 6 |
Showing 12 of 391. All products under Calibrator, Secondary
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142985 | 2015-02-26 |
| K111952 | 2011-08-19 |
| K080166 | 2008-03-19 |
| K070144 | 2007-02-01 |
| K061282 | 2006-06-02 |
| K042651 | 2004-10-05 |
| K012900 | 2001-10-16 |
| K003098 | 2000-11-20 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2012-07-24 | Class II | Nonconforming Material/Component | Beckman Coulter is recalling the Access Folate Calibrators because it may produce falsely elevated results that could mask a folate deficiency. | 5,266 units total (3,214 units in US) | 2013-10-17 |
| 2011-03-11 | Not classified | Pending | The recall was initiated because standardization of the Synchron Systems Calibrator 1, used for both the Synchron LX and UniCel DxC systems, has been established to the new IFCC Reference Preparation for Plasma Proteins, ERM-DA470k (formerl | 96,173 units | 2012-05-04 |
| 2009-12-17 | Not classified | Nonconforming Material/Component | Beckman Coulter has confirmed reports that the Access Free T3 calibrator lot numbers 989902, 989903, 989904, 989905, 989906 and 989907 will show a decline in performance before reaching their stated expiration date. The affected calibrator | 2,320 kits | 2012-03-29 |
| 2009-08-26 | Not classified | Nonconforming Material/Component | A recall was initiated because Beckman has confirmed that the standardization of the Immuno Protein Calibrator Set has been re-established to IFCC Reference Preparation for Plasma Proteins, BCR-470 beginning with lot number M901330. | 1,923 units total (1,882 units in US) | 2012-04-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.