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

Recall Z-1826-2013 — Getinge Assure Accufast BI Test Pack w/ 25 Controls, SteriTec Product Code PL 395/25, Distributor Product Code 61301606639 The Smart-Read Biological Test Pack with Instant Readout Integrator: is designed specifically for biological testing of 3 or 4 minutes or longer at 132 (270 and 3 minutes at

U.S. FDA — Device Enforcement · United States · 2013-06-10 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1826-2013
Date of alert: 2013-06-10
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Steritec Products Mfc. Co., Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 61301606639

Reported risk: Mesa Labs, based out of Bozeman, MT, informed SteriTec Products, Inc. of a product recall involving the EZTest Steam and Smart-Read Biological Indicators (BI) because the readout time is not in specification with the label claims.

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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