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POINTE SCIENTIFIC Calcium Arsenazo

HORIBA INSTRUMENTS INCORPORATED · Model C7529-1L · UDI-DI 00811727010643

CIC Prescription
1
510(k) clearances
236
Adverse events
10
Recalls
19
Facilities

Description

For the quantitative determination of Calcium in serum or heparinized plasma.

Recalls

DateFirmReason
2021-10-22MEDLINE INDUSTRIES, LP - NorthfieldProduct 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
2018-01-30Siemens Healthcare Diagnostics, Inc.May produce erroneously low results from specific well sets.
2016-08-03Siemens 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
2013-09-06Horiba Instruments, Inc dba Horiba MedicalHORIBA 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.
2010-10-11Roche 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.
2010-10-11Roche 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
2009-11-10Pointe Scientific, Inc.Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.
2009-11-10Pointe Scientific, Inc.Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.
2009-11-10Pointe Scientific, Inc.Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.
2006-06-07Roche 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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Data 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.