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CF InPlex ASR Card (2016-03-31)
- Starting date:
- March 31, 2016
- Posting date:
- April 22, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-58022
Affected products
A. CF InPlex ASR Card
Reason
This voluntary recall is being initiated as a result of complaints of false positive het mutations (9 complaints) and leaking cards (2 complaints) reported to Hologic. Internal investigations have determined that the false positives and leakage were most likely caused by manufacturing defect at a key component supplier.
Affected products
A. CF InPlex ASR Card
Lot or serial number
U34AH
U34CI
U34DB
U34GK
U35AV
U35CG
U35CI
Model or catalog number
95-0501
Companies
- Manufacturer
-
Gen-Probe Incorporated, a wholly owned subsidiary of Hologic, Inc.,
10210 Genetic Center Drive,
San Diego.
92121
California
UNITED STATES