Bd Multitest 6-Color Tbnk Reagent, Model 644611

• 2 recalls, same reason

  • Ongoing Z-0172-2023 FDA Class II ·initiated 3 Oct 2022
  • Ongoing Z-0171-2023 FDA Class II ·initiated 3 Oct 2022

  Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant. Firm root cause investigation confirmed that label detachment is due to an adhesive change by a tier 2 supplier.

• • Ongoing Z-0173-2023 FDA Class II ·initiated 3 Oct 2022

  Due to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the automated loader for the wash assistant.

510(k) Number

K090967 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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