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

Recall Z-2351-2015 — PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.

U.S. FDA — Device Enforcement · United States · 2015-06-30 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2351-2015
Date of alert: 2015-06-30
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Remel Inc
Product category: device
Product type: Devices

Reported risk: A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.

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-2351-2015 — PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.

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