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Synermed®
INFRARED LABORATORY SYSTEMS LLC · Model IR240-911 · UDI-DI 05060500090494
CJY
Prescription
1
510(k) clearances
372
Adverse events
10
Recalls
27
Facilities
Description
Calcium Reagent 8 X 250 mL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-09 | Ortho-Clinical Diagnostics, Inc. | Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, cau |
| 2025-04-24 | Mckesson Medical-Surgical Inc. Corporate Office | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failur |
| 2022-02-09 | Siemens Healthcare Diagnostics, Inc. | Siemens Healthcare Diagnostics Inc. has confirmed the potential for reagent carryover impacting quality control (QC), patient samples, and calibrator results. |
| 2018-12-04 | Randox Laboratories Ltd. | Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calciu |
| 2018-12-04 | Randox Laboratories Ltd. | Update to the carryover avoidance technical bulletin to introduce additional steps for reagent carryover avoidance with the Calcium assay on RX instruments. Carryover to the Calciu |
| 2016-05-18 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics (OCD) confirmed a potential for biased calcium (Ca) results to be generated when using VITROS Ca Slides, GEN29, and the VITROS 250/350/950/5,1 FS, 4600 C |
| 2013-09-04 | SEPPIM SAS | Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum. |
| 2013-08-29 | Vital Diagnostics, Inc. | High positive calcium bias on plasma sample versus results on serum |
| 2013-08-29 | Vital Diagnostics, Inc. | High positive calcium bias on plasma sample versus results on serum |
| 2013-06-12 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics is recalling Slide Dispense cartridges used with some VITROS Chemistry Product Slides due to slide dispense issues. |
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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.