Recall Z-1394-2017— Becton Dickinson & Co.
Class II · Terminated
Class II FDA medical device recall by Becton Dickinson & Co., initiated 2015-08-27, terminated 2017-03-06. It names one FDA 510(k) clearance: K931374. Product: BD AffirM VPIII Microbial Identification Test. Reason: BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. This issue would result in an invalid test, as described in the package insert..
- Recalling firm
- Becton Dickinson & Co.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-27
- Terminated
- 2017-03-06
- Firm location
- Sparks, MD, United States
510(k) clearances named in this recall
1 on FDA's recordK-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 AffirM VPIII Microbial Identification Test
Reason for recall
BD has confirmed that a portion of tests associated with the affected lots( 446252 and 446257 ) of product may exhibit blue speckles or fibers on the beads and cards, as shown below. This issue would result in an invalid test, as described in the package insert.
Data sourced from openFDA. This site is unofficial and independent of the FDA.