Z-1133-2010

Martel Printer The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer (model 300). The...

Name: Z-1133-2010 Martel Printer The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer (model 300). The...
Creator: Abbott Point of Care Inc.
Published: 2009-11-06
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-11-06 / Terminated / root cause: design

FDA source

Abbott Point of Care Inc. began a recall of 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... on 2009-11-06. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1133-2010
Status: Terminated
Initiated: 2009-11-06
Posted: 2010-03-15
Terminated: 2011-09-14
Recalling firm: Abbott Medical
Product: 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.
Product code: CGA Glucose Oxidase, Glucose
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: 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.
Quantity in commerce: 6432 printers (1208 have already been returned and repaired or scrapped)
Distribution: Worldwide distribution
Product codes and lots: List number 06F23-91/111300; Abbott list number: 06F23-91 Serial numbers between 20091081 and 241248976.

Product code CGA

K001387Class III-Stat Portable Clinical Analyzer, Model 300I-Stat Corp. / cleared 2000-10-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)