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U.S. Department of Health and Human Services

Class 2 Device Recall ABX Pentra 400

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 Class 2 Device Recall ABX Pentra 400see related information
Date Initiated by FirmFebruary 19, 2016
Create DateApril 22, 2016
Recall Status1 Terminated 3 on August 17, 2016
Recall NumberZ-1553-2016
Recall Event ID 73349
Product Classification Analyzer, chemistry (photometric, discrete), for clinical use - Product Code JJE
ProductABX Pentra 400 (version 5.0.8 or lower) The ABX PENTRA 400 and 400C are discrete photometric bench top chemistry analyzers for clinical use. The device is intended to duplicate manual analytical procedures by performing various steps such as pipetting, mixing, heating and measuring color intensity. The device is intended for use in conjunction with certain materials to measure a variety of analytes.
Code Information All lot/serial #s
Recalling Firm/
Manufacturer		 Horiba Instruments Inc
9755 Research Dr
Irvine CA 92618-4626
For Additional Information Contact
949-250-4811
Manufacturer Reason
for Recall		Horiba Instruments, Inc. is recalling ABX Pentra 400( version 5.0.8 or lower) and Pentra C400 (version 1.1.2 or lower) because clinical chemistry analyzer malfunctions when the following certain alarms appear on the system.
FDA Determined
Cause 2		Software design
ActionHORIBA Medical sent an "Urgent Safety Notice" dated February 19, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. A new software version to solve the issue is currently under development; however the firm requests customers use the provided procedure until the new software version is installed on the system, or be extremely vigilant with results of one of the alarms mentioned appears on the system. The letter instructs customers to share the information with laboratory staff and retain the notification as part of laboratory documentation. The letter states it is mandatory for customers to complete and return the enclosed response form within 10 days, in order to verify understanding of it. Any questions or concerns contact the local Horiba Medical representative. For further questions, please call (949) 250-4811.
Quantity in Commerce201
DistributionUSA (nationwide Distribution) to the states of : CA, NY, AL,OK, MS, MD, NV, MN, TX, KY, WV, MI, NY, MT, IL, FL,WA, ID, MO, WY, NJ, VA, KY, GA, PA, TN, MS, KS, AZ, NE, SC, OR, OH, IA, RI, MI and NC.
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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