Pointe Scientific Creatinine Reagent recall
Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic…
Why was Pointe Scientific Creatinine Reagent recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
C7539-150 Lot: 406201 Batch: 279 Expiration date: 2016-03
- Product
- Pointe Scientific Creatinine Reagent Catalog number C7539-150 in vitro diagnostic C7539-150 kit includes one R1 and one R2 bottle. R1: HDPE plastic…
- Recalling firm
- Pointe Scientific, Inc.
- Quantity
- 93 kits
- Distribution
- Worldwide distribution. US nationwide, Singapore, Kenya, Bolivia, Mexico, Greece, Guyana, and Philippines.
- Recall date
- September 23, 2015
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)