BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray… recallZ-1903-2021 · BioFire Diagnostics, LLC · initiated May 10, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from BioFire Diagnostics, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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 [email protected] or via phone at 1.800.735.6544. 7. Adverse events may also be reported to FDA's MedWatch Adverse Event Reporting program.
Recall details
- Recall number
- Z-1903-2021
- Status
- Terminated
- Initiated by the company
- May 10, 2021
- Recalling firm
- BioFire Diagnostics, LLC
- Quantity
- 870 kits
- Product code
- PEN
- FDA submissions
- K193519
- Distribution
- US nationwide distribution
Product description
BioFire BCID2 Panel, REF RFIT-ASY-0147, For FilmArray Systems, CE, Blood Culture Identification Panel in vitro diagnostic, Rx Only, UDI: (01)00815381020338
Code information (models, lots, serial numbers)
Pouch Lot# 11YA20/ Kit Lot# 2039020. UDI: (01)00815381020338
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BioFire® Blood Culture Identification 2 (BCID2) Panel RFIT-ASY-0147Biofire Diagnostics, LLC · Gram-Positive Bacteria And Their Resistance Markers6 recalls6 deaths555 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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