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Class 2 Device Recall |
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Date Initiated by Firm |
December 21, 2004 |
Date Posted |
March 11, 2005 |
Recall Status1 |
Terminated 3 on June 30, 2005 |
Recall Number |
Z-0611-05 |
Recall Event ID |
30664 |
510(K)Number |
K932642 K972673
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Product |
Vital Scientific brand ISE Snap Pack for use only in the ISE Module 9130, Ref no. 3203-007, Roche part number 03522032001. |
Code Information |
All units. (Sold only outside of the U.S. by Vital in Netherlands). |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corp. 9115 Hague Rd Indianapolis IN 46256-1025
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For Additional Information Contact |
800-526-2272
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Manufacturer Reason for Recall |
A defective seam in the two chamber pouch may result in the mixing of reagents, which would either result in an inability to calibrate the analyzer or would bias patient results.
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FDA Determined Cause 2 |
Other |
Action |
Own name distributor consignees were notified on or about 1/3/05 via letter dated 12/21/04, and were requested to discontinue shipment of the product, notify all of their customers of the recall and to discard product. Roche consignees were notified via letter dated 12/21/04, requested to notify their customers if they had further distributed the product, and instructed to discard all inventory of product. |
Quantity in Commerce |
630 units |
Distribution |
Nationwide, Argentina, Austria, Brazil, Chile, China, Colombia, Ecuador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Panama, Philippines, Poland, Russia, San Salvador, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom and Uruguay. |
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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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510(K) Database |
510(K)s with Product Code = and Original Applicant = AVL SCIENTIFIC CORP.
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