Pointe Scientific CRP(HS) Wide Range Control Set and recall: Labeling Error
Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or…
Why was Pointe Scientific CRP(HS) Wide Range Control Set and recalled?
Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is mg/L.
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 #'s C7568-CTL and C7568-STD Lots: C7568-STD: 717303-131. Exp 6/2009. C7568-CTL: 902701-111 and 902701-131. Exp 1/2011.
- Product
- Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific CRP(HS) Wide Range Standard Set 5 Levels of 1 x 2 ml ready to use calibrator or…
- Recalling firm
- Medtest Holdings, Inc.
- Quantity
- 323 vials
- Distribution
- Worldwide Distribution - US including CA, MS, NJ, PA, HI, MD, FL, OK, NV. Foreign Distribution to CHILE
- Recall date
- July 5, 2017
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)