Counter (beta, Gamma) For Clinical Use
Clinical Chemistry · 21 CFR 862.2320
Recent MDR events
4 adverse event reports on file
- CAPTUS 3000Aug 17, 2012MalfunctionCapintec, Inc.2518443-2012-00001
- AUTO LOGICMar 23, 2012InjuryGetinge (suzhou) Co. Ltd.3005619970-2012-00002
- ACCESS 2 IMMUNOASSAY SYSTEMMay 10, 2006OtherBeckman Coulter, Inc.2122870-2006-00108
- VITROS 950 CHEMISTRY SYSTEMOct 18, 2005MalfunctionOrtho-clinical Diagnostics1319681-2005-00252
Event type breakdown
Most-reported manufacturers
Recalls
14 recall events for this product code
- PerkinelmerTerminatedJan 12, 2016
Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010
The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results.
Z-0632-2016 · View FDA record ↗ - PerkinelmerTerminatedJan 12, 2016
Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020
The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results.
Z-0633-2016 · View FDA record ↗ - PerkinelmerTerminatedJan 12, 2016
Perkin Elmer ClWIZARD2 5-detector, 550 samples
The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results.
Z-0634-2016 · View FDA record ↗ - PerkinelmerTerminatedJan 12, 2016
Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100.
The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results.
Z-0635-2016 · View FDA record ↗ - PerkinelmerTerminatedJan 12, 2016
Perkin Elmer WIZARD2 5-detector, 1000 samples
The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results.
Z-0636-2016 · View FDA record ↗ - PerkinelmerTerminatedJan 12, 2016
Perkin Elmer WIZARD2 10-detector, 1000 samples.
The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results.
Z-0637-2016 · View FDA record ↗ - PerkinelmerTerminatedJan 12, 2016
Perkin Elmer WIZARD2 1-detector,3", 1000 samples.
The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The second barcode ID label #023 symbol incorrectly identifies as #024 when scanned. If measurement protocols have been programmed for both ID #023 and #024, the protocol associated with barcode ID #024 is executed. If the error is undetected, the Gamma Counter may produce erroneous results.
Z-0638-2016 · View FDA record ↗ - PerkinelmerTerminatedJul 20, 2015
Perkin Elmer WIZARD2 1-detector, 550 samples
Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
Z-2124-2015 · View FDA record ↗ - PerkinelmerTerminatedJul 20, 2015
WIZARD2 2-detector, 550 samples
Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
Z-2125-2015 · View FDA record ↗ - PerkinelmerTerminatedJul 20, 2015
WIZARD2 5-detector, 550 samples
Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results
Z-2126-2015 · View FDA record ↗
Registered firms
4 firms currently registered for this product code
510(k) clearances
63 clearances for this product code
- Biotraces, Inc.Aug 16, 1996
K962762 · SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR
- Capintec, Inc.Mar 30, 1995
K946387 · CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER
- Abbott LaboratoriesMar 19, 1992
K920559 · ABBOTT VERTEX ANALYZER
- Laboratory Technologies, Inc.Jul 19, 1990
K900087 · GENESYS 6000 GAMMA COUNTER
- Canberra Industries, Inc.Jan 2, 1990
K896202 · MATRIX(TM)-96
- Oakfield Instruments, Ltd.Oct 17, 1989
K894902 · SOURCERER
- John Caunt Scientific , Ltd.Feb 2, 1989
K884091 · SOURCERER
- Icn Micromedic SystemsJan 9, 1989
K884269 · SAMPLE IDENTIFICATION STATION MODEL 38010