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Abbott m2000 system - m2000sp and m24sp Instrument (2014-08-13)
- Starting date:
- August 13, 2014
- Posting date:
- September 9, 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-41287
Recalled Products
A) Abbott m2000 system - m2000sp Instrument
B) Abbott m24sp
Reason
The X-drive assembly is used in the m2000sp and m24sp instruments. According to X-drive assembly supplier, on one of the two processing machines where the steel wire is pretreated and primed, the wire was polluted by rusty pulleys. Consequently, belts produced from this machine between 01/01/2013 and 09/30/2013, contain rusty wires. Under stress such as routine use of the instruments, this issue can lead to damage of the belt. After days, weeks or sometimes months of operation the belt tension can become weak causing an unusual rattling noise or misalignment.
Affected products
A) Abbott m2000 system - m2000sp Instrument
Lot or serial number
- 10040
- 10057
- 10142
- 10154
- 10171
- 10416
- 10664-10833
Model or catalog number
9K14-02
Companies
- Manufacturer
-
Abbott Molecular Inc.
1300 E. Touhy Ave.
Des Plaines
60018
Illinois
UNITED STATES
B) Abbott m24sp
Lot or serial number
8055
8187-8223
Model or catalog number
03N06-01
Companies
- Manufacturer
-
Abbott Molecular Inc.
1300 E. Touhy Ave.
Des Plaines
60018
Illinois
UNITED STATES