Horiba Instruments, Inc dba Horiba Medical Recall: ABX Pentra Micro ALBUMIN 2 CP, Serum/Pl
Horiba Instruments, Inc dba Horiba Medical Recall: ABX Pentra Micro ALBUMIN 2 CP, Serum/Pl is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Horiba Instruments, Inc dba Horiba Medical; Product: ABX Pentra Micro ALBUMIN 2 CP, Serum/Plasma, REF 1300032563 The device is intended for use in
| Recalling firm | Horiba Instruments, Inc dba Horiba Medical |
|---|---|
| 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 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution: US (nationwide) and to countries of: Bulgaria, Burma, Cameroon, Djibouti, France, Gabon, Germany, Italy, Lebanon, Mali, Mauritania, Poland, Portugal, Romania, Saudi Arabia, South Africa and Thailand. |
| Recall initiated | 20180426 |
| Recall number | Z-2286-2018 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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