Home › Device types › CIC
Cresolphthalein Complexone, Calcium
FDA product code CIC · Class 2 · Clinical Chemistry
47
Registered devices
238
Adverse events
10
Recalls
99
510(k) clearances
Devices with this code
Teco Diagnostics Calcium Reagent Set — TECO DIAGNOSTICSADVIA® Chemistry Calcium Reagents — Siemens Healthcare Diagnostics Inc.Dimension Vista® Flex® reagent cartridge CA — Siemens Healthcare Diagnostics Inc.POINTE SCIENTIFIC Calcium Arsenazo — HORIBA INSTRUMENTS INCORPORATEDClearChem Diagnostics Inc. Calcium — CLEARCHEM DIAGNOSTICS INC.Atellica CH Ca — Siemens Healthcare Diagnostics Inc.Synermed® — INFRARED LABORATORY SYSTEMS LLCCa — RANDOX LABORATORIES LIMITEDCalcium — Roche Diagnostics GmbHCa — RANDOX LABORATORIES LIMITEDCalcium — Roche Diagnostics GmbHAU — Beckman Coulter, Inc.Calcium / BS480 — Medtest Dx, Inc.POINTE SCIENTIFIC Calcium Arsenazo — HORIBA INSTRUMENTS INCORPORATEDADVIA® Chemistry Multi-Drug Urine Controls 1,2 — Siemens Healthcare Diagnostics Inc.Calcium — HORIBA INSTRUMENTS INCORPORATEDPOINTE SCIENTIFIC Calcium (2 part) — HORIBA INSTRUMENTS INCORPORATEDJAS Diagnostics — DREW SCIENTIFIC, INC.Calcium (CPC) LiquiColor® — STANBIO LABORATORY, L.P.POINTE SCIENTIFIC Calcium (2 part) — HORIBA INSTRUMENTS INCORPORATEDPOINTE SCIENTIFIC Calcium Standard — HORIBA INSTRUMENTS INCORPORATEDPointe Scientific, Inc. Calcium — HORIBA INSTRUMENTS INCORPORATEDPointe Scientific — HORIBA INSTRUMENTS INCORPORATEDPointe Calcium Reagent — HORIBA INSTRUMENTS INCORPORATED
Recent 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 thi |
| 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 |
| 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 |
| 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 62601 |
| 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. Interna |
| 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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