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BacT / Alert PF Plus Culture Bottle (2013-10-15)
- Starting date:
- October 15, 2013
- Posting date:
- November 7, 2013
- 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-36635
Recalled Products
BacT / Alert PF Plus Culture Bottle
Reason
BacT / Alert PF Plus Culture bottle, lot 1033633 yielded reflectance results above the stability specification at the 11-month timeframe. Bottles that have reflectance results near or greater than the initial value threshold specification when first loaded on the instrument could have an increased probability of false positive results.
Affected products
BacT / Alert PF Plus Culture Bottle
Lot or serial number
- 1033633
Model or catalog number
- 410853
Companies
- Manufacturer
-
bioMerieux, Inc.
100 Rudolphe Street
Durham
27712
North Carolina
UNITED STATES