| | Class 2 Device Recall Eridan Automated slide stainer. |  |
| Date Initiated by Firm | October 02, 2006 |
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| Date Posted | November 21, 2006 |
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| Recall Status1 |
Terminated 3 on February 01, 2007 |
| Recall Number | Z-0199-2007 |
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| Recall Event ID |
36597 |
| Product Classification |
Automated slide stainer - Product Code KPA
|
| Product | Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1, Dako Colorado, Inc.
(Catalog No. (ER 00130,00331,00230,00431) |
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| Code Information |
Serial numbers: ER103, ER105, ER106, ER107, ER108, ER110, ER111, ER113, ER115, ER117, ER118. |
| FEI Number |
3004485389
|
Recalling Firm/
Manufacturer |
Dako Colorado, Inc.
4850 Innovation Dr
Fort Collins CO 80525-5576
|
| For Additional Information Contact |
970-226-2200 |
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Manufacturer Reason
for Recall | Automated slide staining device may not stain speciman slides correctly, and therefore slides cannot be used for patient diagnosis. |
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FDA Determined
Cause 2 | Other |
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| Action | Consignees were notified by phone on 10/02/2006 and later by letter on 10/20/2006. They were given the option of using the stainer as 'Research Use Only' or having the stainer returned to Dako. |
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| Quantity in Commerce | 11 units |
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| Distribution | Worldwide distribution --- USA including states of CA, IN, NC, WA and countries of Denmark, France, Germany, and Spain. |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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