Recall Z-2286-2018— Horiba Instruments, Inc dba Horiba Medical
Class II · Terminated
Class II FDA medical device recall by Horiba Instruments, Inc dba Horiba Medical, initiated 2018-04-26, terminated 2019-09-26. FDA's recall record names no specific 510(k) clearance for this event. Product: ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.. Reason: When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately after an ABX Pentra Creatinine 120 CP (CREA3) Reagent 2 dispense, the final result of the microalbumin may be elevated more than 10%. This increase may affect serum, plasma and urine sample types..
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-04-26
- Terminated
- 2019-09-26
- Firm location
- Irvine, CA, United States
Product description
ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in conjunction with certain materials to measure a variety of analytes.
Reason for recall
When the ABX Pentra Micro ALBUMIN 2 CP (ALBT2) Reagent 2 is sampled and dispensed immediately after an ABX Pentra Creatinine 120 CP (CREA3) Reagent 2 dispense, the final result of the microalbumin may be elevated more than 10%. This increase may affect serum, plasma and urine sample types.
Data sourced from openFDA. This site is unofficial and independent of the FDA.