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HemosIL Calcium Chloride 0.020M (for SynthASil SynthAFax)
INSTRUMENTATION LABORATORY COMPANY · Model 00020006900 · UDI-DI 08426950087632
GFO
Prescription
1
510(k) clearances
96
Adverse events
10
Recalls
15
Facilities
Description
HemosIL Calcium Chloride 0.020M (for SynthASil SynthAFax)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-12-11 | Instrumentation Laboratory | Potential for microbial contamination. |
| 2025-11-18 | Instrumentation Laboratory | Recalled lots were manufactured with double the amount of preservative concentration. |
| 2021-01-05 | Helena Laboratories, Corp. | Intermittent potential for shorter than expected clot times. |
| 2018-11-14 | Diagnostica Stago, Inc. | There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds. |
| 2018-11-14 | Diagnostica Stago, Inc. | There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds. |
| 2017-12-07 | Helena Laboratories, Corp. | Some of the cards show occasional shorter clot times than the expected variation resulting in a potential false negative result on the screening assay. |
| 2015-03-25 | Siemens Healthcare Diagnostics, Inc. | Recovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT range and/or >15% in the pathological range has been observed. Patient samples wit |
| 2013-12-19 | ITC-Nexus Dx | ITC has determined that some Citrate APTT cuvettes may recover higher than expected results in normal individuals. |
| 2006-07-18 | Diagnostica Stago, Inc. | Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants. |
| 2004-03-01 | Dade Behring , Inc. | cloudy appearance or precipitate |
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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.