Medtest CRP Calibrator and Standard Sets Recalled for Unit Mislabeling
Medtest Holdings is recalling Pointe Scientific CRP calibrator and standard sets because vial labels incorrectly list units as mg/dl instead of mg/L.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a minor labeling error regarding units of measurement.
Plain-English summary
Medtest Holdings, Inc. is recalling Pointe Scientific CRP(HS) Wide Range Control Sets and Standard Sets. The recall involves 323 vials of ready-to-use calibrators and standards intended for the calibration of the manufacturer's CRP (High Sensitivity) Wide Range immunoturbidimetric assay. The products are for in vitro diagnostic use only.
The recall was initiated because individual vials were mislabeled. Specifically, the units on the vial labels are incorrectly listed as mg/dl, whereas the correct unit is mg/L. This labeling error could lead to incorrect calibration of the diagnostic assay.
The affected products include Model #s C7568-CTL and C7568-STD. Specific lots include C7568-STD lot 717303-131 (Exp 6/2009) and C7568-CTL lots 902701-111 and 902701-131 (Exp 1/2011). The products were distributed worldwide, including in the US (CA, MS, NJ, PA, HI, MD, FL, OK, NV) and Chile. Users should stop using the affected vials and contact Medtest Holdings for further instructions.
The recalled product
- 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 standard The Pointe Scientific CRP (HS) Wide Range Multi-Calibrator Set is intended to be used for the calibration of the…
- Manufacturer
- Medtest Holdings, Inc.
- Hazard
- Affected units
- 323
Distribution
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