Martel Printer The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer (model 300). The i-STAT Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include Hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide, and pH), Creatinine, lactate and activated clotting time.
This recall has been terminated (originally issued March 15, 2010).
- Company
- Abbott Point Of Care Inc.
- Recall Initiated
- November 6, 2009
- Posted
- March 15, 2010
- Terminated
- September 14, 2011
- Recall Number
- Z-1133-2010
- Quantity
- 6432 printers (1208 have already been returned and repaired or scrapped)
- Firm Location
- Princeton, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
Some Martel Printers used with the i-STAT 1 system have the potential of being damaged due to the use or rechargeable battery packs that do not contain a fuse.
Distribution
Worldwide distribution
Lot / Code Info
List number 06F23-91/111300; Abbott list number: 06F23-91 Serial numbers between 20091081 and 241248976.
Root Cause
Component design/selection
Action Taken
An "Urgent Recall Notice" dated October 2009 was sent to customers. The notice described the product, problem and action to be taken by the customers. The customers are requested to remove the printers from use, if they have a Martel printer with the specified serial numbers, that do not have a battery door for access to the rechargeable battery pack. The customers are ask to turn in to Abbott Point of Care or a designated repair facility, all affected Martel printers for battery pack replacement. Abbott will return the Martel printers to your facility at no charge. The customers are ask to please follow the instructions on the enclosed customer reply cared. If in doubt regarding identification of the affected Martel printers, contact Abbott Point of Care Technical Support. If you have any questions regarding this information or if removing the affected Martel printers from use will negatively impact patient care, please contact Abbott Point of Care Technical Support at 800-366-8020, option 1 or your Abbott Point of Care representative.