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CAROLINA LIQUID CHEMISTRIES CORP.® APOB RGT. KIT BL-633
CAROLINA LIQUID CHEMISTRIES CORPORATION · Model BL633 · UDI-DI 00817302020892
DER
Prescription
10
510(k) clearances
3
Adverse events
2
Recalls
11
Facilities
Description
APO B (Apolipoprotein B) 2 x 100 tests
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-05-16 | Abbott Laboratories, Inc | An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products. |
| 2005-11-10 | Abbott Laboratories Diagnostic Div | These specific protein assays are not meeting the 57-day on board stability claim |
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