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FDA (Device enforcement)Recalled 2019-05-13closedclass ii

Becton Dickinson & Company: BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974

Is my product affected?

BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974

  • UPC 30382903659747
  • UPC 50382903659741

Check against the official notice below — it lists the full affected range.

What happened

Becton Dickinson & Company is recalling BD MicrotainerTubes with K2E (K2EDTA), catalog number 365974, due to damaged reservoirs that may result in decreased fill volume. This defect can cause blood samples to be insufficient for testing and create an improper blood-to-additive ratio, potentially leading to erroneous test results. The affected tubes were distributed nationwide and internationally across multiple countries including Canada, Mexico, Japan, Australia, and many others.

The recall affects multiple lot numbers, including 8101695, 8101696, 8101699, 8101701, 8106835, 8106837, 8106842, 8106847, 8106850, 8120851, 8121979, 8121981, 8124783, 8124880, and 8127770. The source document does not specify what remedy or action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.

Details from the source

Reason for recall: Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results. Distribution: Nationwide Foreign: AR AU BE BN BR CA CL CN CO CR CW EC GT GY HK HN ID IN JP KR MX MY NI NZ PA PE PG PH PK SG SR SV TH TW UY VN Quantity: N/A Lot/code info: Lot Number/UDI: 8101695 (01)30382903659747 (17)190930(10)8081695(30)50 (17)190930(10)8101695(30)200(01)50382903659741 8101696 (01)30382903659747 (17)190930(10)8081696(30)50 (17)190930(10)8101696(30)200(01)50382903659741 8101699 (01)30382903659747 (17)190930(10)8101699(30)50 (17)190930(10)8101699(30)200(01)50382903659741 8101701 (01)30382903659747 (17)190930(10)8101701(30)50 (17)190930(10)8101701(30)200(01)50382903659741 8106835 (01)30382903659747 (17)190930(10)8106835(30)50 (17)190930(10)8106835(30)200(01)50382903659741 8106837 (01)30382903659747 (17)190930(10)8106837(30)50 (17)190930(10)8106837(30)200(01)50382903659741 8106842 (01)30382903659747 (17)190930(10)8106842(30)50 (17)190930(10)8106842(30)200(01)50382903659741 8106847 (01)30382903659747 (17)190930(10)8106847(30)50 (17)190930(10)8106847(30)200(01)50382903659741 8106850 (01)30382903659747 (17)190930(10)8106850(30)50 (17)190930(10)8106850(30)200(01)50382903659741 8120851 (01)30382903659747 (17)191031(10)8120850(30)50 (17)191031(10)8120850(30)200(01)50382903659741 8121979 (01)30382903659747 (17)191031(10)8121979(30)50 (17)191031(10)8121979(30)200(01)50382903659741 8121981 (01)30382903659747 (17)191031(10)8121981(30)50 (17)191031(10)8121981(30)200(01)50382903659741 8124783 (01)30382903659747 (17)191031(10)8124783(30)50 (17)191031(10)8124783(30)200(01)50382903659741 8124880 (01)30382903659747 (17)191031(10)8124880(30)50 (17)191031(10)8124880(30)200(01)50382903659741 8127770 (01)30382903659747 (17)191031(10)8127770(30)50 (

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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