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THE EDGE Lactate Control Solution
APEX BIOTECHNOLOGY CORP. · Model The EDGE control solution · UDI-DI 04713648766554
10
510(k) clearances
169
Adverse events
19
Recalls
46
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-29 | Ortho-Clinical Diagnostics, Inc. | VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 |
| 2025-07-29 | Ortho-Clinical Diagnostics, Inc. | VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 |
| 2020-01-15 | Abbott Point Of Care Inc. | The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA recognizes two types of laboratory tests: waived and non-waived. Different |
| 2018-12-17 | Roche Diagnostics Corporation | New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D mod |
| 2016-10-11 | Abbott Laboratories | Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21). |
| 2016-08-11 | Ortho-Clinical Diagnostics | Ortho Clinical Diagnostics confirmed that N-Acetylcysteine (NAC), a drug used for acetaminophen overdose, mucolytic therapy and is used as nutritional supplement, can interfere wit |
| 2016-07-05 | Siemens Healthcare Diagnostics Inc | Some v2.2.2 upgrade kits include a dialysate mode which not cleared/approved for shipment in the United States |
| 2016-04-13 | Beckman Coulter Inc. | Beckman Coulter has identified that Dipyrone (Metamizole) may cause erroneous, false low results in the following assays: Cholesterol OSR6X16, Triglyceride OSR6X118, Uric Acid OSR6 |
| 2016-01-11 | Horiba Instruments Inc | N-Acetylcysteine (NAC) present in the blood of patients treated for paracetamol overdose can interfere with the Trinder reaction that uses hydrogen peroxide catalytic on aminoantip |
| 2015-08-24 | Siemens Healthcare Diagnostics Inc | RAPIDPoint 500 measurement cartridge serial numbers 2517102517 through 2519000012, negative sodium bias on both QC and patient results |
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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.