Home › Siemens Healthcare Diagnostics Inc. › Dimension Vista® Flex® reagent cartridge AMY
Dimension Vista® Flex® reagent cartridge AMY
Siemens Healthcare Diagnostics Inc. · Model 10445154 · UDI-DI 00842768015069
1
510(k) clearances
15
Adverse events
2
Recalls
32
Facilities
Description
Amylase Flex® reagent cartridge, 360 tests
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-07-10 | RANDOX LABORATORIES, LTD. | Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020. |
| 2007-12-03 | Roche Diagnostics Corp. | False Results- The reagent of the LDL-Cholesterol assay shows a carryover effect on the Lipase assay. Results may be falsely elevated by up to 50 units per liter when used on COBA |
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