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IMMULITE® 2000 Systems TGB TBG Sample Diluent
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Model 10387072 · UDI-DI 00630414954271
1
510(k) clearances
0
Adverse events
1
Recalls
9
Facilities
Description
TBG Sample Diluent - IMMULITE - CAL - 1x25mL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-04-09 | Siemens Healthcare Diagnostics, Inc. | IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parameter of <1.80. The resulting slope of the kit is >1.80 resulting in the potential t |
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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.