FDA Medical Device Recalls (openFDA)
Pointe Scientific, Inc.: Alcohol Reagent Set for the quantitative determination of ethyl alcohol in serum, Imported and marketed in India by Ranbaxy Laboratories Ltd., New Delhi; Catalog # A7504-150-S.
- Recall number
- Z-1544-06
- Recalling firm
- Pointe Scientific, Inc.
- Product
- Alcohol Reagent Set for the quantitative determination of ethyl alcohol in serum, Imported and marketed in India by Ranbaxy Laboratories Ltd., New Delhi; Catalog # A7504-150-S.
- Status
- Terminated
- Initiated
- 2006-06-09
- Posted
- 2006-09-30
- Terminated
- 2007-11-20
- Reason
- Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.
- Root cause
- Other
- Action
- Consignees were notified via recall letter dated 6/9/06 and a second letter dated 6/21/06 extending the recall to additional products/lots, to cease using the products, conduct a recall to the user level, destroy products on hand and to notify the firm via the response form of the amount destroyed for replacement purposes.
- Quantity
- 5 units
- Distribution
- Worldwide distribution ---- including USA and countries of Canada, Ecuador, Germany, Greece, India, Mexico, Peru, Poland, Portugal, Trinidad, United Arab Emirates and United Kingdom.
- Lot, serial or model codes
- Lot 507401.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JIX
- Firm FEI
- 1827821
- Firm city
- Canton
- Firm state
- MI
- 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