BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338
- Company
- Biofire Diagnostics, Llc
- Recall Initiated
- May 10, 2021
- Terminated
- December 15, 2022
- Recall Number
- Z-1903-2021
- Quantity
- 870 kits
- Firm Location
- Salt Lake City, UT
Reason for Recall
Elevated rates of false negative results may occur when using blood culture panels due to issues in the manufacturing process. Pouches contained OPP from FilmArray Blood Culture Identification Panel (BCID) instead of OPP from BCID2 Panel.
Distribution
US nationwide distribution
Lot / Code Info
Pouch Lot# 11YA20/ Kit Lot# 2039020. UDI: (01)00815381020338
Root Cause
Process control
Action Taken
On 5/10/21, BioFire distributed a "Urgent: Medical Device Correction" letter to all consignees via: E-Mail. In addition to providing consignees with a recall notification, the firm ask consignees to take the following actions: 1 Immediately examine your inventory for product identified in this recall (BCI 2 Panel Pouch Lot # 11YA20/ Kit Lot # 2039020). 2. Discontinue use and discard any remaining product in your possession that is subject to this recall. BioFire will replace the product at no charge in accordance with Biofire's Standard limited Warranty 3.Confirm the amount of pouches scrapped (if any) on the attached acknowledgement of receipt form. 4. If you may have further distributed this product, please identify any recipients and notify them at once of this product recall. 5. Please complete the accompanying Field Action acknowledgement of receipt Form and return to BioFire so that BioFire may acknowledge your receipt of this notification. 6. If you have any questions or concerns, please contact our customer support department at support@biofiredx.com or via phone at 1.800.735.6544. 7. Adverse events may also be reported to FDA's MedWatch Adverse Event Reporting program.