Bayer brand Technicon RA/opeRA Systems ISE Fluid Pack for in vitro diagnostic use on the opeRA system only, Manufacturer
FDA device recall Z-0608-05 · posted 2005-03-11 · Terminated
Recall details
- Recalling firm
- Roche Diagnostics Corp.
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 3181 units
- Distribution
- Nationwide, Argentina, Austria, Brazil, Chile, China, Colombia, Ecuador, France, Germany, Guatemala, India, Indonesia, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Panama, Philippi
- Date initiated
- 2004-12-21
- Date posted
- 2005-03-11
- Date terminated
- 2005-06-30
- Location
- Indianapolis, IN
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Related 510(k) clearances
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| AVL 9181 ELECTROLYTE ANALYZER (K972673) | Avl Scientific Corp. | 1997-08-20 |
| AVL 9110PH ANALYZER (K932642) | Avl Scientific Corp. | 1993-10-14 |