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ThinPrep Processors (2015-06-24)
- Starting date:
- June 24, 2015
- Posting date:
- July 8, 2015
- 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-54120
Recalled Product
A. ThinPrep 2000 Processor
B. ThinPrep 5000 Processor
Reason
Hologic has recently been notified by Health Canada regarding classification of the Thinprep 2000 and Thinprep 5000 Processors. These products entered the Canadian market as class i devices and it has been determined that these should be classified as class iii. This reclassification is the result of an administrative error and is completely unrelated to the safety and effectiveness of the Thinprep Processors. There are no issues or concerns with the safe and effective use of the Thinprep 2000 or the Thinprep 5000 Processors and the integrity of all past, current and future tests are not in question.
Affected products
A.ThinPrep 2000 Processor
Lot or serial number
All Lots
Model or catalog number
- 70031-001
- 70031-002
Companies
- Manufacturer
-
Hologic, Inc.
250 Campus Drive
Marlborough
01752
Massachusetts
UNITED STATES
B. ThinPrep 5000 Processor
Lot or serial number
All Lots
Model or catalog number
- 71362-001
- 71362-002
Companies
- Manufacturer
-
Hologic, Inc.
250 Campus Drive
Marlborough
01752
Massachusetts
UNITED STATES