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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the STARLYTE III electrolyte analyzer, Roche part number 03361152001.
Brand
Roche Diagnostics Corp.
Lot Codes / Batch Numbers
All units.
Products Sold
All units.
Roche Diagnostics Corp. is recalling Alfa Wassermann brand REF E1-8 STARLYTE III ISE Fluid Pack for use in the STARLYTE III electrolyte a due to 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. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026