Z-1072-03

IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M3586A)...

Name: Z-1072-03 IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M3586A)...
Creator: Diametrics Medical, Inc.
Published: 2003-07-14
License: https://open.fda.gov/license/

Diametrics Medical, Inc. / initiated 2003-07-14 / Terminated

FDA source

Diametrics Medical, Inc. began a recall of IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M3586A). There are 25 disposable cartridges in a box of IRMA SL... on 2003-07-14. The reason FDA records is "An incorrect lot designation, when entered into the blood analysis device, caused the device to give an error message and not operate". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1072-03
Status: Terminated
Initiated: 2003-07-14
Posted: 2003-07-30
Terminated: 2004-07-02
Recalling firm: Diametrics Medical, Inc.
Product: IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M3586A). There are 25 disposable cartridges in a box of IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridges, Part Number 039903(M3586A).
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Reason for recall: An incorrect lot designation, when entered into the blood analysis device, caused the device to give an error message and not operate.
FDA root cause: Other
Action: The consignees were notified of the recall by telephone on July 14, 2003 and requested to return the product.
Quantity in commerce: 103 boxes of 25 cartridges each.
Distribution: The product was shipped to 13 hospitals in California, Colorado, Florida, Iowa, Kansas, Minnesota, New Hamshire, Texas, and Wisconsin.
Product codes and lots: The lot on the boxes of the product is ALHCB (this is the correct lot) and is incorrectly printed as ALOHC on the packages of the recalled disposable cartridges.

Product code JJE

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)