Medical Device Recalls
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1 to 6 of 6 Results
510(K) Number: K052007 |
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Results per Page |
Product Description
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Recall
Class |
FDA Recall
Posting Date |
Recalling Firm
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10 ML REAGENT CUP, B1034626, SAP 1221034626 for use with ABX PENTRA 400 / PENTRA C400 | 2 | 01/31/2018 | Horiba Instruments, Inc dba Horiba Medical |
15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PENTRA C400 | 2 | 01/31/2018 | Horiba Instruments, Inc dba Horiba Medical |
ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnost... | 2 | 02/02/2016 | Horiba Instruments Inc |
ABX PENTRA Reagent Container, Model No. B1037307 (15 mL), B1034626 (10 mL), and B1034634 (4 mL) | 2 | 01/02/2015 | Horiba Instruments, Inc dba Horiba Medical |
ABX PENTRA N Control, Model No. A11A01653 The ABX PENTRA N Control is for use in quality control ... | 2 | 01/31/2014 | Horiba Instruments, Inc dba Horiba Medical |
HORIBA ABX PENTRA 400 I.S.E. Module, Model Numbers: P400ISE110EN02 and P400ISE110US02, All Serial Nu... | 2 | 04/18/2013 | Horiba Instruments, Inc dba Horiba Medical |
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