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POINTE SCIENTIFIC Calcium Standard

HORIBA INSTRUMENTS INCORPORATED · Model C7503-STD · UDI-DI 00811727010650

CIC Prescription

510(k) clearances

237

Adverse events

Recalls

Facilities

Description

Intended for use as an calcium standard for standardization or calibration of cresolphthalein complexone (CPC) or arsenazo calcium procedures.

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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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.