Pointe Scientific Chemistry Controls Level I and II recall
Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.
Why was Pointe Scientific Chemistry Controls Level I and II recalled?
The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.
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?
Model Number(s): C7590-50 (Chemistry Control Level I), C7591-50 (Chemistry Control Level II), and C7592-100 (Chemistry Control Level I and II).
- Product
- Pointe Scientific Chemistry Controls Level I and II LEVl: Amber glass vial w/PP white plastic cap. LEV2: Amber glass vial w/PP black plastic cap.
- Recalling firm
- Medtest Holdings, Inc.
- Quantity
- 132919 Vol vials
- Distribution
- Nationwide
- Recall date
- May 31, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)