The Recall Desk
Agency classClass IIIOur severity:LowFDA (Devices)·Z-2121-2017·Announced 2017-05-31

Medtest Recalls Pointe Scientific Chemistry Controls Due to Mean Assignment Error

Medtest Holdings is recalling Pointe Scientific Chemistry Controls Level I and II because the original mean assigned to the controls was too high, resulting in a new assigned mean outside the published range.

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 data assignment error affecting accuracy rather than a direct safety hazard like contamination or physical defect.

Plain-English summary

Medtest Holdings, Inc. is recalling Pointe Scientific Chemistry Controls Level I and II. The affected products include amber glass vials with white or black plastic caps, identified by model numbers C7590-50, C7591-50, and C7592-100. The recall covers 132,919 vials distributed nationwide.

The recall was initiated because the original mean assigned to the control was too high. Upon reassignment with additional data, the new assigned mean was found to be outside of the originally published range. This discrepancy affects the accuracy of the control values used in laboratory testing.

Consumers and laboratories should stop using the affected products and contact Medtest Holdings for further instructions or a refund. The recall is classified as Class III by the FDA, indicating that use of the product is not likely to cause adverse health consequences.

The recalled product

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.
Manufacturer
Medtest Holdings, Inc.
Category
Medical Device — Laboratory Controls
Hazard
Affected units
132,919

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model Number(s): C7590-50 (Chemistry Control Level I)
  • C7591-50 (Chemistry Control Level II)
  • and C7592-100 (Chemistry Control Level I and II).

Distribution

Distributed nationwide across the United States.

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