FDA Medical Device Recalls (openFDA)
Roche Diagnostics Corp.: Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the STARLYTE III electrolyte analyzer, Roche part number 03361152001.
- Recall number
- Z-0609-05
- Recalling firm
- Roche Diagnostics Corp.
- Product
- Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the STARLYTE III electrolyte analyzer, Roche part number 03361152001.
- Status
- Terminated
- Initiated
- 2004-12-21
- Posted
- 2005-03-11
- Terminated
- 2005-06-30
- Reason
- 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.
- Root cause
- 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
- 5222 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.
- Lot, serial or model codes
- All units.
- 510(k) numbers
- ["K932642","K972673"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1823260
- Firm city
- Indianapolis
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28