| Class 2 Device Recall | |
Date Initiated by Firm | December 21, 2004 |
Date Posted | March 11, 2005 |
Recall Status1 |
Terminated 3 on June 30, 2005 |
Recall Number | Z-0605-05 |
Recall Event ID |
30664 |
510(K)Number | K932642 K972673 |
Product | Roche brand ISE SnapPak for use only in the AVL 9120/9130 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN; Ref/No. 03112276180; Part number BP5016. |
Code Information |
All units. |
Recalling Firm/ Manufacturer |
Roche Diagnostics Corp. 9115 Hague Rd Indianapolis IN 46256-1025
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For Additional Information Contact | 800-526-2272 |
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. |
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 | 20116 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 =
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