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Pointe Scientfic, Inc.
HORIBA INSTRUMENTS INCORPORATED · Model HA965-324 · UDI-DI 00811727012562
CIJ
Prescription
10
510(k) clearances
1
Adverse events
1
Recalls
6
Facilities
Description
Amylase EPS Reagent Set for the quantitative kinetic determination of a-amylase activity in human serum. For in vitro diagnostic use only. Packaged at 12 x 22ml, 6 x 10ml
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2020-07-10 | RANDOX LABORATORIES, LTD. | Amylase AY3805 batch 480449 and Pancreatic Amylase AY3855 batch 480483 have failed to meet the quoted performance claims prior to expiry on 28th Sept 2020. |
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