Recall Z-2286-2018 ยท PFT Reagents For Molecular Diagnostic Test Systems
Horiba Instruments, Inc dba Horiba Medical
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.
| Date | Apr 26, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| Action | The firm, Horiba Medical, sent a "FIELD SAFETY NOTICE" dated April 26, 2018 to the customers on the customer list on April 26, 2018. The notice described the product, problem and actions to be taken. The notice directed the consignee to manually program the system to address the issue and the share the information with the laboratory staff and to complete and return the enclosed Acknowledgment Form within 10 days via Fax: (949)753-0533, Email: azita.hedayati@horiba.com or Mail: HORIBA Medical, 9755 Research Dr., Irvine, CA 92618. If you have any questions regarding this Product Corrective A |
| Quantity | 686 devices (233 devices US, 453 devices OUS) |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.