BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plu
FDA device recall Z-1139-2024 · posted 2024-02-15 · Open, Classified
Recall details
- Recalling firm
- BioFire Diagnostics, LLC
- Reason for recall
- Due to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums
- Action taken
- On 01/26/2024, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via overnight FedEx to customers to inform them of the increased risk of false positive Candida tropicalis results when the BIOFIRE BCID2 Panel is used with BD BACTEC blood culture vials including, but not limited to, the bottle types: BD BACTEC" Lytic Anaerobic medium BD BACTEC" Peds Plus medium BD BACTEC" Plus Aerobic medium BD BACTEC" Plus Anaerobic medium BD BACTEC" Standard Aerobic medium BD BACTEC" Standard Anaerobic medium Customers are requested to take the following actions: - If the BIOFIRE BCID2 Panel is used to test BD BACTEC blood culture vials, positive results for Candida tropicalis should be confirmed by another method prior to reporting the test results. - Distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, and forward this information to all parties that may use this product, including others to whom they may have transferred the product. - Complete the Acknowledgement Form in Attachment A and return it to bioMerieux so that bioMerieux may acknowledge their receipt of this notification. It is important that they return the acknowledgement form to bioMerieux even if they determine that this urgent field safety notice does not impact their facility. For questions/assistance contact BIOFIRE Technical Support Team at biofiresupport@biomerieux.com or via telephone at 1-800-735-6544 and select option 5.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- PEN
- Quantity affected
- 32,910 panels/pouches
- Distribution
- Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ
- Date initiated
- 2024-01-26
- Date posted
- 2024-02-15
- Location
- Salt Lake City, UT
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BioFire Blood Culture Identification 2 (BCID2) Panel (K193519) | Biofire Diagnostics, LLC | 2020-03-18 |