| Date Initiated by Firm | May 20, 2004 |
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| Date Posted | April 13, 2005 |
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| Recall Status1 |
Terminated 3 on July 22, 2006 |
| Recall Number | Z-0703-05 |
|---|
| Recall Event ID |
30931 |
| 510(K)Number | K884125 |
|---|
| Product Classification |
Device, Microtiter Diluting/Dispensing - Product Code JTC
|
| Product | Version 7 Software for wash program on Bio Tek Automated Microplate Washer Model ELx50 which performs the washing steps for various programmed mictotiter plate assays. |
|---|
| Code Information |
version 7 |
| FEI Number |
2182595
|
Recalling Firm/
Manufacturer |
Diasorin Inc.
1951 Northwestern Ave S
Stillwater MN 55082-7536
|
| For Additional Information Contact | DiaSorin Technical Services
800-328-1482 |
|---|
Manufacturer Reason
for Recall | When software was updated for the Washer program of the Bio Tek Automated Microplate Washer Model ELx50, the software did not automatically clear old versions of the wash program when new ones were added. |
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FDA Determined
Cause 2 | Other |
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| Action | Customers were notified by phone and informed of the problem and recommended users to use only the newer wash program which is identified is a 'W' in front of the program. |
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| Quantity in Commerce | 9 |
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| Distribution | CA, FL, NH, PA, SD, TX, WA |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = JTC
|
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