Recall Z-1072-03 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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).
| Date | Jul 30, 2003 (initiated Jul 14, 2003) |
| Status | Terminated |
| Reason | An incorrect lot designation, when entered into the blood analysis device, caused the device to give an error message and not operate. |
| Root cause | Other |
| Action | The consignees were notified of the recall by telephone on July 14, 2003 and requested to return the product. |
| Quantity | 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. |
| FDA record | Open on fda.gov |