SoftLab
64 catalogue numbers from 4.5.8.2, listed by SCC Soft Computer, United States, under Calculator/Data Processing Module, For Clinical Use. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
64catalogue numbers in this listing
19recalls on this code
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Foshan Zike Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 9 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
| Shanghai Bestcovered Limited | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | SCC Soft Computer, United States |
|---|---|
| FDA product code | JQP |
| Device type | Calculator/Data Processing Module, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2100 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-05-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4.5.8.2 | In distribution | |
| 4.1.17.23 | In distribution | |
| 4.1.17.233 | In distribution | |
| 5.0.0.12 | In distribution | |
| 4.1.17.246 | In distribution | |
| 4.5.8.11 | In distribution | |
| 4.1.17.250 | In distribution | |
| 4.1.17.241 | In distribution | |
| 4.5.7.10 | In distribution | |
| 4.1.17.234 | In distribution | |
| 4.5.8.6 | In distribution | |
| 4.5.8.5 | In distribution | |
| 4.0.9.1 | In distribution | |
| 4.5.8.3 | In distribution | |
| 4.5.7.4 | In distribution | |
| 4.5.7.5 | In distribution | |
| 4.1.18.0 | In distribution | |
| 4.5.5.60 | In distribution | |
| 4.1.17.14 | In distribution | |
| 4.5.7.8 | In distribution | |
| 4.1.17.247 | In distribution | |
| 4.0.8.4 | In distribution | |
| 5.0.0.10 | In distribution | |
| 4.5.5.70 | In distribution | |
| 4.1.17.255 | In distribution | |
| 4.5.7.7 | In distribution | |
| 4.1.17.244 | In distribution | |
| 4.1.17.240 | In distribution | |
| 4.1.17.20 | In distribution | |
| 4.1.17.248 | In distribution | |
| 4.1.17.243 | In distribution | |
| 4.1.17.242 | In distribution | |
| 4.5.7.3 | In distribution | |
| 4.5.8.1 | In distribution | |
| 4.5.8.0 | In distribution | |
| 4.1.17.235 | In distribution | |
| 4.1.17.10 | In distribution | |
| 4.1.17.232 | In distribution | |
| 4.1.17.230 | In distribution | |
| 4.5.8.4 | In distribution | |
| 4.5.5.52 | In distribution | |
| 4.1.17.251 | In distribution | |
| 4.5.5.80 | In distribution | |
| 4.1.17.17 | In distribution | |
| 4.1.17.252 | In distribution | |
| 4.1.17.239 | In distribution | |
| 4.5.8.10 | In distribution | |
| 4.1.17.238 | In distribution | |
| 4.1.17.12 | In distribution | |
| 4.5.8.7 | In distribution | |
| 4.1.17.30 | In distribution | |
| 5.0.0.6 | In distribution | |
| 4.1.17.253 | In distribution | |
| 4.1.17.245 | In distribution | |
| 4.1.17.236 | In distribution | |
| 4.0.9.0 | In distribution | |
| 4.0.9.2 | In distribution | |
| 4.1.17.249 | In distribution | |
| 4.1.17.237 | In distribution | |
| 4.5.7.9 | In distribution | |
| 4.5.7.6 | In distribution | |
| 4.1.17.254 | In distribution | |
| 5.0.0.3 | In distribution | |
| 4.5.5.51 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SoftPathDx | SCC Soft Computer | 69 |
| SoftMolecular | SCC Soft Computer | 67 |
| SoftFlowCytometry | SCC Soft Computer | 67 |
| SoftBiochemistry | SCC Soft Computer | 67 |
| SoftCytogenetics | SCC Soft Computer | 67 |
| SoftMic | SCC Soft Computer | 65 |
| SoftTrack | SCC Soft Computer | 61 |
| SoftHLA | SCC Soft Computer | 61 |
| SoftGenomics | SCC Soft Computer | 51 |
| SoftGenePortal | SCC Soft Computer | 48 |
| SoftTotalQC | SCC Soft Computer | 28 |
| Rals | Abbott Rapid Diagnostics Informatics, Inc. | 14 |
Showing 12 of 140. All products under Calculator/Data Processing Module, For Clinical Use
Recalls
6 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 |
|---|---|---|---|---|---|
| 2021-03-31 | Class II | Software design (manufacturing process) | Software is given wrong results going out to HIS on test that had reruns. | 5 | 2023-02-14 |
| 2021-03-31 | Class II | Software Design Change | Software showing wrong results reported, PDF not match HIS. | 1 | 2022-04-15 |
| 2014-11-26 | Class II | Software design | Modifications to diagnostic text may be: 1) Saved to the database but not appear on the report sent to the physician; or 2) Documented on the report, but not saved to the database. | 108 units | 2016-05-16 |
| 2014-05-20 | Class II | Device Design | The interface fails to send abnormal flags for Reference Lab test results. | 48 | 2016-05-16 |
| 2014-01-29 | Class II | Software design | When an isolate is resulted without a SNOMED code, isolate information in the downstream system may be incomplete or missing. As a result, there is the potential for the delay or omission of patient treatment updates. | 1 | 2014-11-03 |
| 2011-10-17 | Class II | Software design | On 10/17/2011 SCC Soft Computer, Clearwater, FL initiated a correction on SoftLab with SA INST versions: 3.1.6.12, 4.0.1.26-4.0.1.32, 4.0.2.21-4.0.2.51, and 4.0.3.5-4.0.3.13. A client reported an issue which caused two different sets of res | 88 | 2014-09-03 |
| 2011-08-25 | Not classified | Software design | On 08/25/2011, SCC Soft Computer initiated a correction on the following SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7. For clients using SoftMic Result Entry, when a certain series of keystrokes on the test grid are performed whi | 144 | 2014-10-03 |
| 2011-08-08 | Not classified | Software design | On 08/08/2011 SCC Soft Computer, Clearwater, FL initiated a correction on following SoftLab used with: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x. A client reported a flagging error where the result | 255 | 2013-11-22 |
| 2011-07-26 | Not classified | Software design | SCC Soft Computer, Clearwater, FL, initiated a correction for the SoftLab used with SA INST. A test performed on the Roche Cobas Integra series of instruments when used with the GenInst/Dispatch listening program could cause incorrect flagg | 265 | 2013-05-21 |
| 2011-07-20 | Not classified | Software design | On 07/20/2011 SCC Soft Computer, Clearwater, FL, initiated a correction on the following SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12. A client reported that the HPV results on a patient report were incorrect. The HPV results | 97 | 2013-05-21 |
| 2011-07-13 | Not classified | Software design | Soft Computer, Clearwater, FL, initiated a correction on the following SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4. SoftPath architecture does not correctly handle AP macros and data fields inside report se | 142 | 2012-07-17 |
| 2011-05-03 | Not classified | Software design | On 05/03/2011, SCC Soft Computer, Clearwater, FL, initiated a correction on the following SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16; 4.0.4 | 220 | 2013-08-07 |
| 2010-06-01 | Not classified | Software design | Functionality issue: For clients using the instrument to generate results on the interface menu, two different result records could be displayed under the same order and sequence numbers. This could cause incorrect results to be populated | 40 | 2012-07-16 |
| 2010-02-16 | Not classified | Software design | When a test is being verified, the wrong (expired) ranges may be associated to that test result, causing an incorrect flag to be posted for that test result. | 31 | 2012-07-17 |
| 2009-04-01 | Not classified | Software design | Clients using Patient Maintenance to perform Moves of Stays may send the wrong billing number during an ADT update to SoftWeb, SoftPath or SoftMedia. The wrong billing number can come from a different patient in Order Entry. Only Moves of | 49 | 2013-08-07 |
| 2006-02-23 | Not classified | Other | Loss of text misrepresented individual tissue diagnosis on the final diagnosis print out from the HIS system software. The specimen heading “J” was removed and the diagnosis appeared under the specimen heading “I” as a result the specimen | 335 | 2008-11-20 |
| 2006-02-23 | Not classified | Software design | In the creation of revised report and supplemental reports diagnosis, text was inserted from another case. | 201 | 2008-11-20 |
| 2004-10-27 | Not classified | Other | Text from one case is overwriting another. This could cause an incorrect diagnostic report to be sent to a clinician/surgeon. | 4 | 2010-07-19 |
| 2001-01-09 | Not classified | Other | The client had made a decision to use the SoftPath Module in a nonstandard manner. Under specific circumstances, incorrect text may appear on a patient report. | 171 | 2010-07-19 |
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.