Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

Pointe Scientific CRP(HS) Wide Range Control Set and Pointe Scientific Recalled by Medtest Holdings, Inc. Due to Mislabeling

Date: July 21, 2009
Company: Medtest Holdings, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Medtest Holdings, Inc. directly.

Affected Products

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

Quantity: 323 vials

Why Was This 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.

Where Was This Sold?

This product was distributed to 9 states: CA, FL, HI, MD, MS, NV, NJ, OK, PA

Affected (9 states)Not affected

About Medtest Holdings, Inc.

Medtest Holdings, Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report