Recall Z-1098-2021 ยท JFP Electrode, Ion Specific, Calcium
Roche Diagnostics Operations, Inc.
9180 Electrolyte Analyzer - Product Usage: intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in the whole blood, serum or plasma, urine, dialysate solutions, or QC materials. catalog number 03157334001 . in vitro diagnostic use.
| Date | Feb 8, 2021 (initiated Jan 6, 2021) |
| Status | Terminated |
| Reason | May display Calcium results on the screen with wrong arrow direction which may lead to misinterpretation of results and incorrect medical decision. If the unit for iCa++ is set to mg/dL (configured as Service Code MGL) and a measured iCa++ value is lower than the normal range, an upward arrow is shown on the display instead of a downward arrow. The display is set per default to mmol/L; therefore, the arrow indicating an alarm reflects normal ranges of iCa++ in mmol/L. If mg/dL is chosen, the arrow warnings on screen still reflect the ranges from mmol/L, rather than mg/dL. The numeric result is |
| Root cause | Software design |
| Action | Roche issued Urgent Medical Correction Letter on 1/6/2021, Urgent Medical Device Correction TP-01190 and Distributor UMDC TP-01192 mailed via UPS Ground. For iCa++ results, rely on the numeric value and units on the printout, rather than the analyzer display. Investigate where a change in result reporting could impact patient management. Consult with the physician, pathologist, or Laboratory Director at your facility to determine specific clinical implications for your patients. **** UPDATE 2/7/22: Customer Bulletin TP-01454 Customer Bulletin-Roche 9180 Electrolyte Analyzer Discontinuation o |
| Quantity | 1,214 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961458 | AVL 9180 ELECTROLYTE ANALYZER Avl Scientific Corp., Jun 12, 1996 |