bacT/ALERT FN Plus (2019-03-25)
- Starting date:
- March 25, 2019
- Posting date:
- April 18, 2019
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-69618
Last updated: 2019-04-18
Affected Products
bacT/ALERT FN Plus
Reason
The issue was discovered during a complaint investigation. An error message was generated by the VIRTUO instrument that incorrectly indicated the bottle would be expiring before the end of the culture bottle test cycle. This error message was displayed on the VIRTUO system at the customer's site. The human readable expiration date on the bottle label was correct and the bottle had not expired. The source of the error message was determined to be an incorrect expiration date within the 2D barcode on the bottle label.
Affected products
bacT/ALERT FN Plus
Lot or serial number
- 4051547
- 4051577
- 4051727
Model or catalog number
410852
Companies
- Manufacturer
-
Biomerieux Inc.
100 Rudolphe Street
Durham
27712
North Carolina
UNITED STATES