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Pointe Calcium Arsenazo for BS480
HORIBA INSTRUMENTS INCORPORATED · Model 14-C7529-360 · UDI-DI 00811727015754
CIC
Prescription
1
510(k) clearances
237
Adverse events
10
Recalls
19
Facilities
Description
Pointe Calcium Arsenazo packaged for the BS480 analyzer. 6x60mL Kit. For the quantitative determination of Calcium in serum or heparinized plasma. For in vitro diagnostic use only.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-10-22 | MEDLINE INDUSTRIES, LP - Northfield | Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium r |
| 2018-01-30 | Siemens Healthcare Diagnostics, Inc. | May produce erroneously low results from specific well sets. |
| 2016-08-03 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics determined that the Dimension Vista Calcium (CA) Flex reagent cartridge lot # 16060BB may produce erroneously low or high results from specific well |
| 2013-09-06 | Horiba Instruments, Inc dba Horiba Medical | HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent. |
| 2010-10-11 | Roche Diagnostics Operations, Inc. | The firm has recieved complaints of imprecision and erroneous patient results for calcium on the COBAS INTEGRA and COBAS c 501 system using reagent lots 62601901 and 63020401. |
| 2010-10-11 | Roche Diagnostics Operations, Inc. | Internal investigations have confirmed imprecision and erroneous patient results (up to 35% discrepant results) for specific lots of the Calcium assay. Internal investigations rev |
| 2009-11-10 | Pointe Scientific, Inc. | Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated. |
| 2009-11-10 | Pointe Scientific, Inc. | Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated. |
| 2009-11-10 | Pointe Scientific, Inc. | Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated. |
| 2006-06-07 | Roche Diagnostics Corp. | Falsely low patient and control results may be reported when the reagent has been on-board for less than the 8 hour use period specified in the labeling. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.