Home › Device types › JJF
Analyzer, Chemistry, Micro, For Clinical Use
FDA product code JJF · Class 1 · Clinical Chemistry
30
Registered devices
93
Adverse events
13
Recalls
57
510(k) clearances
Devices with this code
COBAS®TaqMan® 48 Analyzer — Roche Molecular Systems, Inc.Diamedix — DIAMEDIX CORPORATIONcobas c 311 — Roche Diagnostics GmbHSPOTCHECK — ASTORIA-PACIFIC, INC.LIAISON® Easy Starter Kit — DIASORIN S.P.A.cobas 6000 core unit — Roche Diagnostics GmbHcobas c 501 Module — Roche Diagnostics GmbHLIAISON® XL — DIASORIN SPASPOTCHECK — ASTORIA-PACIFIC, INC.Alere Cholestech LDX® — Alere San Diego, Inc.MedTest DX Wash Solution for the BS200 — Medtest Dx, Inc.ISE DIL URN — RANDOX LABORATORIES LIMITEDSABS — RANDOX LABORATORIES LIMITEDCholestech LDX™ — Alere San Diego, Inc.Wash Concentrate 1 — Medtest Dx, Inc.WASH conc. 1 — RANDOX LABORATORIES LIMITEDRX daytona — RANDOX LABORATORIES LIMITEDCholestech LDX™ — Alere San Diego, Inc.V-Twin® — VitalScientific B.V.Cl SOLN — RANDOX LABORATORIES LIMITEDRABS — RANDOX LABORATORIES LIMITEDCOBAS® TaqMan® — Roche Molecular Systems, Inc.NS — RANDOX LABORATORIES LIMITEDSOLN WASH — RANDOX LABORATORIES LIMITED
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-11-15 | Vital Scientific N.V. | During in-house testing it was determined that their is a possibility that during a sample run, the instrument may aspirate a sample from the wrong sample cont |
| 2018-09-07 | Vital Scientific N.V. | The action is being initiated because the cooling indicator board was improperly installed. This was first noticed by a service employee during assembly. If fo |
| 2016-01-18 | Vital Scientific N.V. | Instrument stopped working due to a software lockup, and no patient results are produced. |
| 2012-02-01 | Roche Molecular Systems, Inc. | Certain lots of COBAS AmpliPrep (CAP) S-tube Input (Box of 12 bags 12x24 S-tube and 12x24 S-clip) can cause the sample input tubes to stick in the barcode clips |
| 2012-01-10 | Vital Scientific N.V. | The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced. |
| 2012-01-10 | Vital Scientific N.V. | The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced. |
| 2012-01-10 | Vital Scientific N.V. | The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced. |
| 2007-08-30 | Roche Diagnostics Corp. | False Negative Results: Air bubbles in the lens or the area surrounding the lens of the LightCycler 100 uL capillaries may cause false negative results. The aff |
| 2007-05-21 | Roche Molecular Systems, Inc. | For select COBAS AMPLICOR Tests run on the COBAS AMPLICOR Analyzer in conjunction with AMPLILINK software, a discrepancy has been identified between the onboard |
| 2005-11-23 | Beckman Coulter Inc | Under certain conditions an incorrect Tube ID (Barcode) can be displayed and printed on the Runtime Panel Report in CXP Cytometer Software Version 2.0 |
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