Z-2328-2009

Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack. Printing results of...

Name: Z-2328-2009 Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack. Printing results of...
Creator: Abbott Point of Care Inc.
Published: 2009-04-22
License: https://open.fda.gov/license/

Abbott Medical / initiated 2009-04-22 / Terminated / root cause: manufacturing process

FDA source

Abbott Point of Care Inc. began a recall of Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack. Printing results of clinical chemistry tests and test panels... on 2009-04-22. The reason FDA records is "It appears that the rechargeable battery pack is overheating with or without the presence of smoke". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2328-2009
Status: Terminated
Initiated: 2009-04-22
Posted: 2009-09-30
Terminated: 2010-02-25
Recalling firm: Abbott Medical
Product: Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack. Printing results of clinical chemistry tests and test panels contained in the i-STAT test cartridges.
Product code: CGA Glucose Oxidase, Glucose
Reason for recall: It appears that the rechargeable battery pack is overheating with or without the presence of smoke.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Urgent Recall Notice letters dated April 2009 were sent out the third week of April by Federal Express. The letter discussed the background, required actions, and additional information. Customers are to identify all affected Martel printer rechargeable battery packs, record the number of affected packs on the attached business reply cards, and return the card along with the affected batteries as instructed. Questions should be directed to Abbott Technical Support at 800-366-8020.
Quantity in commerce: 2552
Distribution: Worldwide Distribution
Product codes and lots: Printer i-STAT Catalog number 06723-91; battery pack catalog number 06F21-35. Martel Printers with serial numbers 281071578 to 281071977; 281174571 to 281174970; 281276302 to 281276701 and 290178290 to 290178689. Repaired printers received since November 4, 2008; Replacement chargeable battery packs received since October 30, 2008.

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)