Recall record at a glance
| Official record | Z-2631-2017 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | Medtest Holdings, Inc. |
| Report date | Jul 5, 2017 |
| Recall initiation date | Jul 21, 2009 |
| Quantity | 323 vials |
| Location | Canton, MI, United States |
Official product description
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 standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only. The Pointe Scientific CRP (HS) Wide Range Multi-Standard Set Is intended to be used for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbimidmetric assay. For in vitro diagnostic use only
Why the product was 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.
Distribution information
Worldwide Distribution - US including CA, MS, NJ, PA, HI, MD, FL, OK, NV. Foreign Distribution to CHILE
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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