Ammonia/alcohol Control Set for the quantitative determination of ammonia/alcohol in blood, Manufactured for Pointe Scientific, Inc.; Catalog number A7504-CTL.
This recall has been terminated (originally issued September 30, 2006).
- Company
- Pointe Scientific, Inc.
- Recall Initiated
- June 9, 2006
- Posted
- September 30, 2006
- Terminated
- November 20, 2007
- Recall Number
- Z-1543-06
- Quantity
- 44 units
- Firm Location
- Canton, MI
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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 / Code Info
Lot 522202, exp. 7/06.
Root Cause
Other
Action Taken
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.