Recall Z-0056-2020— Becton Dickinson & Company
Class II · Terminated
Class II FDA medical device recall by Becton Dickinson & Company, initiated 2019-05-13, terminated 2020-08-06. It names 2 FDA 510(k) clearances: K002456, K991702. Product: BD Microtainer SST Part/Catalog No.365967. Reason: 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..
- Recalling firm
- Becton Dickinson & Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-05-13
- Terminated
- 2020-08-06
- Firm location
- Franklin Lakes, NJ, United States
510(k) clearances named in this recall
2 on FDA's record- K002456 — MICROTAINER BRAND SODIUM FLUORIDE/EDTA TUBE WITH MICROGARD CLOSURE, MODEL 365992
- K991702 — MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
BD Microtainer SST Part/Catalog No.365967
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.