Alk Phos R2 (also labeled as Alkaline Phosphatase R2) Reagent; Catalog Nos. 7-A7516-R2-125, 7-A7516-R2-90 and 8-A7516-R2-30, In vitro diagnostic, 30 mL, 90 mL , 125 mL, and 400 mL containers, Sold by Pointe Scientific.
This recall has been terminated (originally issued March 27, 2008).
- Company
- Pointe Scientific, Inc.
- Recall Initiated
- February 7, 2008
- Posted
- March 27, 2008
- Terminated
- June 12, 2009
- Recall Number
- Z-1359-2008
- Quantity
- 47
- Firm Location
- Canton, MI
- Official Source
- View on FDA website ↗
Reason for Recall
May be contaminated with microorganisms.
Distribution
Worldwide-USA, Canada, Chile, Cyprus, Ecuador, Greece, India, Italy, Jamaica, Korea, Nigeria, Pakistan, Philippines, Poland, Turkey and The West Indies.
Lot / Code Info
All Lots beginning with 727801; exp. 4/09.
Root Cause
Other
Action Taken
Consignees were notified via recall letter, Urgent Medical Device, dated 2/7/08, to cease using the product, conduct a recall to the user level, destroy product on hand and to notify the firm via the response form of the amount destroyed for replacement purposes. International consignees were notified via email.
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