Roche brand ISE SnapPak for use only in the AVL 9110/9140 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN.; Ref/No. 03112314018, Part number BP5032.
Recall
- Recall Number
- Z-0607-05
- Event Number
- 30664
- Firm
- Roche Diagnostics Corp.
- FEI Number
- 1823260
- Status
- Terminated
- Root Cause
- Other
- Initiated
- December 21, 2004
- Posted
- March 11, 2005
- Terminated
- June 30, 2005
- Address
- 9115 Hague Rd, Indianapolis, IN, 46256-1025
Description
Roche brand ISE SnapPak for use only in the AVL 9110/9140 Electrolyte Analyzer Assembled and distributed by Roche Diagnostics Corp., Indpls., IN.; Ref/No. 03112314018, Part number BP5032.
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.
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.
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.
9280 units