Pointe Scientific Creatinine Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # C7539-150, C7539-625, C7539-625-S, C7539-1250, HC939-756, HC939-1340, 12-C7539-98, 8-C7539-R1-120, 8-C7539-R1-500, 8-C7539-R1-1000, 7-C7539-R1-120, 7-C7539-R1-1000, and 7-C7539-R1-500. For the quantitative determination of creatinine in serum. For in-vitro diagnostic use only.
Recall
- Recall Number
- Z-1035-2010
- Event Number
- 54094
- Firm
- Pointe Scientific, Inc.
- FEI Number
- 1827821
- Product Code
- CGX
- Status
- Terminated
- Root Cause
- Process change control
- Initiated
- December 1, 2009
- Posted
- March 9, 2010
- Terminated
- October 15, 2010
- Address
- 5449 Research Dr, Canton, MI, 48188
Description
Pointe Scientific Creatinine Reagent Set, Pointe Scientific, Inc., Canton, MI; Catalog # C7539-150, C7539-625, C7539-625-S, C7539-1250, HC939-756, HC939-1340, 12-C7539-98, 8-C7539-R1-120, 8-C7539-R1-500, 8-C7539-R1-1000, 7-C7539-R1-120, 7-C7539-R1-1000, and 7-C7539-R1-500. For the quantitative determination of creatinine in serum. For in-vitro diagnostic use only.
An additional 10% picric acid was added to the R2 component during production.
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.
Worldwide Distribution -- USA, Bolivia, Greece, Guyana, India, Indonesia, Israel, Kenya, Korea, Malaysia, Mexico, Pakistan, Philippines, Russia, Serbia, Sri Lanka, Tanzania, Trinidad and Ukraine.
892 kits