Diametrics Medical, Inc. 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). Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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).
Brand
Diametrics Medical, Inc.
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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.
Diametrics Medical, Inc. is recalling IRMA SL Blood Analysis System CC pH, pCO2, pO2, Hct, Na+, K+, iCa Cartridge, Part Number 039903(M358 due to An incorrect lot designation, when entered into the blood analysis device, caused the device to give an error message and not operate.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An incorrect lot designation, when entered into the blood analysis device, caused the device to give an error message and not operate.
Recommended Action
Per FDA guidance
The consignees were notified of the recall by telephone on July 14, 2003 and requested to return the product.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, FL, IN, IA, KS, MN, TX, WI
Page updated: Jan 10, 2026