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I-STAT 1 ANALYZER (SOFTWARE) (2017-11-09)
- Starting date:
- November 9, 2017
- Posting date:
- November 30, 2017
- 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-65264
Affected products
I-STAT 1 ANALYZER (SOFTWARE)
Reason
Abbott Point of Care has determined that i-STAT Total b-hCG cartridges may produce an increased number of quality check code (QCC) 149 when used with i-STAT 1 Analyzer software version JAMS 143 / CLEW A34. Root cause analysis has determined that this is a software issue.
Affected products
I-STAT 1 ANALYZER (SOFTWARE)
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
03P75-06
04P75-01
06F16-10
Companies
- Manufacturer
-
Abbott Point of Care Inc.
100 and 200 Abbott Park Rd.
Abbott Park
60064
Illinois
UNITED STATES