Alere Cholestech LDX®
Alere Cholestech LDX® Multianalyte Controls (2 X 2ml)
1manufacturer
2catalogue numbers in this listing
9recalls on this code
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Getein Biotech, Inc. | Nanjing | Jiangsu | Manufacturer | 19 |
Record
| Listed by | Alere San Diego, Inc., United States |
|---|---|
| FDA product code | JJY |
| Device type | Multi-Analyte Controls, All Kinds (Assayed) |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K102700 |
| Record published | 2018-03-30 |
| Record revised | 2026-03-13 (version 4) |
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, serial number |
| Storage | Handling environment temperature 2 to 30 °C |
| Distribution end date | 2023-08-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 88773 | Withdrawn | |
| 88769 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Liquichek | Bio-Rad Laboratories Inc. | 154 |
| Validate | LGC Clinical Diagnostics, Inc. | 120 |
| InteliQ | Bio-Rad Laboratories Inc. | 50 |
| Lyphochek | Bio-Rad Laboratories Inc. | 39 |
| Stat Profile | Nova Biomedical Corporation | 38 |
| i-STAT | Abbott Point OF Care Inc. | 24 |
| Multichem AE | Techno-Path Manufacturing Ltd. | 20 |
| Serum Control | Chromsystems Instruments & Chemicals Gmbh | 18 |
| BioPlex 2200 | Bio-Rad Laboratories Inc. | 16 |
| Nova | Nova Biomedical Corporation | 14 |
| Plasma Control | Chromsystems Instruments & Chemicals Gmbh | 14 |
| Multichem IA Speciality | Techno-Path Manufacturing Ltd. | 12 |
Showing 12 of 559. All products under Multi-Analyte Controls, All Kinds (Assayed)
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Alere San Diego, Inc. | 510(k) number | 2015-08-27 | Class III | Error in labeling | Alere San Diego is recalling the Alere Cholestech LDX Multianalyte Control because the assigned control ranges for the Total Cholesterol (TC) and Triglyceride (TRG) analytes are incorrect. | 190 kits | 2015-12-22 |
| Alere San Diego, Inc. | 510(k) number | 2012-10-22 | Class III | Component design/selection | Out of range (increased) HDL Cholesterol results. | 11,166 kits | 2013-09-26 |
| Alere San Diego, Inc. | 510(k) number | 2012-10-22 | Class III | Component design/selection | Out of range (increased) HDL Cholesterol results. | 614 kits | 2013-09-26 |
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 |
|---|---|---|---|---|---|
| 2016-10-12 | Class II | Employee error | Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card. | 513 kits | 2017-07-24 |
| 2010-10-06 | Not classified | Pending | The recall was initiated because results were being reported as being out of range. Firm is reassigning ranges for HDL cholesterol in product. | 3,382 kits | 2012-08-01 |
| 2010-10-06 | Not classified | Pending | The recall was initiated because results were being reported as being out of range. Firm is reassigning ranges for HDL cholesterol in product. | 917 kits | 2012-08-01 |
| 2010-10-06 | Not classified | Pending | The recall was initiated because results were being reported as being out of range. Firm is reassigning ranges for HDL cholesterol in product. | 1,092 kits | 2012-08-01 |
| 2010-10-06 | Not classified | Pending | The recall was initiated because results were being reported as being out of range. Firm is reassigning ranges for HDL cholesterol in product. | 388 kits | 2012-08-01 |
| 2010-10-06 | Not classified | Pending | The recall was initiated because results were being reported as being out of range. Firm is reassigning ranges for HDL cholesterol in product. | 750 kits | 2012-08-01 |
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.