Pointe Scientific Creatinine Reagent R2, Pointe Scientific, Inc., Canton, MI; Catalog 3-C7539-L, 7-C7539-R2-30, 7-C7539-R2-125, 7-C7539-R2-250, 8-C7539-R2-30, 8-C7539-R2-125 and 8-7539-R2-250. For the quantitative determination of creatinine in serum. For in-vitro diagnostic use only.
This recall has been terminated (originally issued March 9, 2010).
- Company
- Pointe Scientific, Inc.
- Recall Initiated
- December 1, 2009
- Posted
- March 9, 2010
- Terminated
- October 15, 2010
- Recall Number
- Z-1036-2010
- Quantity
- 625 vials
- Firm Location
- Canton, MI
- Official Source
- View on FDA website ↗
Reason for Recall
An additional 10% picric acid was added to the R2 component during production.
Distribution
Worldwide Distribution -- USA, Bolivia, Greece, Guyana, India, Indonesia, Israel, Kenya, Korea, Malaysia, Mexico, Pakistan, Philippines, Russia, Serbia, Sri Lanka, Tanzania, Trinidad and Ukraine.
Lot / Code Info
All lots numbers containing the numbers 923202; exp. 2011-08.
Root Cause
Process change control
Action Taken
Consignees were notified by An Urgent: Medical Device Recall letter, dated 12/1/09, that identified the affected product. Customers were asked to immediately examine their inventory for the affected product and to notify any customers that the product may have been further distributed to by giving them a copy of the recall notice. Customers are to dispose of the affected product immediately. Questions should be directed to the Technical Support Department at (800)757-5313 or (734)487-8300. There is also a Recall Response form attached with this notice.