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

Recall Z-2631-2017 — 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

U.S. FDA — Device Enforcement · United States · 2009-07-21 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2631-2017
Date of alert: 2009-07-21
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Medtest Holdings, Inc.
Product category: device
Product type: Devices

Reported risk: 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.

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.

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