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Cresolphthalein Complexone, Calcium

FDA product code CIC · Class 2 · Clinical Chemistry

47
Registered devices
236
Adverse events
10
Recalls
99
510(k) clearances

Devices with this code

Ca — RANDOX LABORATORIES LIMITEDPointe Calcium Arsenazo for BS480 — HORIBA INSTRUMENTS INCORPORATEDSynermed® — INFRARED LABORATORY SYSTEMS LLCPOINTE SCIENTIFIC Calcium Arsenazo — HORIBA INSTRUMENTS INCORPORATEDADVIA® Chemistry CPC Calcium Reagents — Siemens Healthcare Diagnostics Inc.Calcium — HORIBA INSTRUMENTS INCORPORATEDPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDPointe Scientific, Inc. Calcium — HORIBA INSTRUMENTS INCORPORATEDAU — Beckman Coulter, Inc.Calcium — Roche Diagnostics GmbHPOINTE SCIENTIFIC Calcium Arsenazo — HORIBA INSTRUMENTS INCORPORATEDTeco Diagnostics Calcium Reagent Set — TECO DIAGNOSTICSCalcium — Roche Diagnostics GmbHPOINTE SCIENTIFIC Calcium Standard — HORIBA INSTRUMENTS INCORPORATEDPointe Calcium Reagent — HORIBA INSTRUMENTS INCORPORATEDCalcium Arsenazo III Reagent — CLINICAL DIAGNOSTIC SOLUTIONS, INC.Dimension Vista® Flex® reagent cartridge CA — Siemens Healthcare Diagnostics Inc.JAS Diagnostics — DREW SCIENTIFIC, INC.Synermed® — INFRARED LABORATORY SYSTEMS LLCAtellica CH Ca — Siemens Healthcare Diagnostics Inc.Ca — RANDOX LABORATORIES LIMITEDPointe Scientific, Inc. — HORIBA INSTRUMENTS INCORPORATEDDimension® Flex® reagent cartridge CA — Siemens Healthcare Diagnostics Inc.ADVIA® Chemistry Calcium Reagents — Siemens Healthcare Diagnostics Inc.

Recent 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 thi
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
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
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 62601
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. Interna
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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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.