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5mL Reaction Vessels used with the m2000sp Instrument (2014-07-09)
- Starting date:
- July 9, 2014
- Posting date:
- August 8, 2014
- 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-40947
Recalled products
- 5mL Reaction Vessels used with the m2000sp Instrument
Reason
During run setup on a M2000SP instrument a customer found two 5 ml reaction vessels, list number 04J71-20, with missing rims that fell through the 1ml subsystem carrier. Some of the 5 ml reaction vessels (RV) in the affected lots may have an insufficient rim. A RV with an insufficient rim may not be held securely in the 1ml subsystem carrier. This may cause the RV to be seated incorrectly in the carrier or drop through it.
Affected products
A. 5mL Reaction Vessels used with the m2000sp Instrument
Lot or serial number
- 56944001
- 57026001
- 57059001
- 57673001
Model or catalog number
- 04J71-20
Companies
- Manufacturer
-
Abbott Molecular Inc.
1300 E. Touhy Ave.
Des Plaines
60018
Illinois
UNITED STATES