Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2121-2017 — 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.

U.S. FDA — Device Enforcement · United States · 2014-05-15 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2121-2017
Date of alert: 2014-05-15
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Medtest Holdings, Inc.
Product category: device
Product type: Devices

Reported risk: The original mean assigned to the control too high, upon reassignment with additional data the new assigned mean was outside of the originally published range.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-2121-2017 — 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.

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