FDA Medical Device Recalls (openFDA)
Horiba Instruments, Inc dba Horiba Medical: ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
- Recall number
- Z-0902-2015
- Recalling firm
- Horiba Instruments, Inc dba Horiba Medical
- Product
- ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL)
- Status
- Terminated
- Initiated
- 2014-11-13
- Posted
- 2015-01-02
- Terminated
- 2015-03-19
- Reason
- HORIBA Medical is recalling the ABX PENTRA 400 Reagent Container because they do not always sit properly into the reagent rack. In low reagent level scenarios, this could lead to insufficient reagent volume being pipetted and could lead to incorrect results being reported without an alarm. The defect would result in a false high or false low results for HbA1c and false high results for magnes
- Root cause
- Package design/selection
- Action
- A recall letter was sent on 11/13/14 to all customers who purchased the ABX PENTRA 400 Clinical Chemistry Analyzer. The letter informs the customer of the problems identified and the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to contact their local HORIBA Medical representative.
- Quantity
- 443 units
- Distribution
- Nationwide in US
- Lot, serial or model codes
- Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL) manufactured since June 2014.
- 510(k) numbers
- ["K052007"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 3002698356
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28