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U.S. Department of Health and Human Services

Class 2 Device Recall ABX Pentra Micro ALBUMIN 2 CP

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 Class 2 Device Recall ABX Pentra Micro ALBUMIN 2 CPsee related information
Date Initiated by FirmApril 26, 2018
Create DateJune 25, 2018
Recall Status1 Terminated 3 on September 26, 2019
Recall NumberZ-2286-2018
Recall Event ID 80022
Product Classification Reagents for molecular diagnostic test systems - Product Code PFT
ProductABX 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.
Code Information All lot numbers; Software Version(s): Application versions below (V5.14 & V2.12) for Pentra 400 and Versions below (V1.07) for Pentra C400
FEI Number 3002698356
Recalling Firm/
Manufacturer		 Horiba Instruments, Inc dba Horiba Medical
34 Bunsen
Irvine CA 92618-4210
For Additional Information Contact
949-453-0500 Ext. 208
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionThe 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 Action, please contact your local Horiba Medical representative or our Technical Service Department at 888-903-5001, option 3, option 2.
Quantity in Commerce686 devices (233 devices US, 453 devices OUS)
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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