Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic bottle. 120 ml fill. R2: HDPE plastic bottle. 90 ml fill.
This recall has been terminated (originally issued September 16, 2015).
- Company
- Pointe Scientific, Inc.
- Recall Initiated
- December 12, 2014
- Posted
- September 16, 2015
- Terminated
- October 29, 2015
- Recall Number
- Z-2773-2015
- Quantity
- 93 kits
- Firm Location
- Canton, MI
- Official Source
- View on FDA website ↗
Reason for Recall
Creatinine kit C7539-150 contains Creatinine reagent R1 that is labeled as Creatinine reagent R2 (30ml) and reagent R2 vial is labeled as R1 (120ml). With manual procedure, no result will be reported as the control will be out of specifications.
Distribution
Worldwide distribution. US nationwide, Singapore, Kenya, Bolivia, Mexico, Greece, Guyana, and Philippines.
Lot / Code Info
C7539-150 Lot: 406201 Batch: 279 Expiration date: 2016-03
Root Cause
Process control
Action Taken
On 12/12/2014, Field Correction Notice notifications were sent to the affected distributors via electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Any questions concerning the corrective action may be directed to Pointe Scientifics Technical Service Department at 1-800-757-5313.