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

Recall Z-2764-2015 — Pointe Scientific autoHDL Reagent H7545 H7545-R1 in a bulk cube container or HDPE plastic bottle H7545-1000 kit includes 1x750 ml of R1 and 1x250 ml of R2 12-H7545-162 kit includes 3x40 ml of R1 and 3x14 ml of R2 HDL600 kit includes 3x40 ml of R1 and 3x14 ml of R2 Kits: HDPE plastic bottle

U.S. FDA — Device Enforcement · United States · 2015-03-13 · Class III

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2764-2015
Date of alert: 2015-03-13
Country / jurisdiction: United States
Risk level: Class III
Risk type: recall
Brand: Pointe Scientific, Inc.
Product category: device
Product type: Devices

Reported risk: Crystals may be observed in the R1 reagent. Crystals may be a result of the reagent being frozen during transport. The crystals do not impact product performance.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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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