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FDA Medical Device Recalls (openFDA)

Abbott Point of Care Inc.: 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.

Recall number
Z-2328-2009
Recalling firm
Abbott Point of Care Inc.
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.
Status
Terminated
Initiated
2009-04-22
Posted
2009-09-30
Terminated
2010-02-25
Reason
It appears that the rechargeable battery pack is overheating with or without the presence of smoke.
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
2552
Distribution
Worldwide Distribution
Lot, serial or model codes
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.
510(k) numbers
["K001387"]
PMA numbers
not on file
Product code
CGA
Firm FEI
2245578
Firm city
East Windsor
Firm state
NJ
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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