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Teco Diagnostics Calcium Reagent Set
TECO DIAGNOSTICS · Model C503-480 · UDI-DI 10673486001365
CIC
Prescription
1
510(k) clearances
238
Adverse events
10
Recalls
21
Facilities
Description
Teco Diagnostics Calcium Reagent Set is used for the direct, colorimetric determination of calcium in human serum or urine.
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.