| Date Initiated by Firm | July 17, 2006 |
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| Date Posted | August 05, 2006 |
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| Recall Status1 |
Terminated 3 on December 04, 2007 |
| Recall Number | Z-1372-06 |
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| Recall Event ID |
35790 |
| Product Classification |
Test, Factor V Leiden Mutations, Genomic Dna Pcr - Product Code NPQ
|
| Product | Roche MagNA Pure LC System (RMD); Catalog no. 03670325001. An automated, general purpose instrument for isolation and purification of nucleic acids and assembly of PCR reactions. |
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| Code Information |
All units. |
Recalling Firm/
Manufacturer |
Roche Diagnostics Corp.
9115 Hague Rd
Indianapolis IN 46256-1025
|
| For Additional Information Contact |
800-262-4911 |
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Manufacturer Reason
for Recall | If the user opens the instrument lid during decontamination, the cycle will stop, but the timer will continue, resulting in the user believing the instrument has been decontaminated when it has not . |
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FDA Determined
Cause 2 | Other |
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| Action | Consignees were notified via recall letter dated 7/17/06 to restart the sterilization cycle if they open the instrument for any reason during the sterilization cycle. |
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| Quantity in Commerce | 771 total for recalls Z-1372-1374-06 |
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| Distribution | Nationwide. |
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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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