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Alinity m
ABBOTT MOLECULAR INC. · Model 09N20-002 · UDI-DI 00884999047693
10
510(k) clearances
80
Adverse events
3
Recalls
22
Facilities
Description
Alinity m Ethanol Solution
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2010-09-29 | Becton Dickinson & Co. | In vitro diagnostic reagent packs may be underfilled and contribute to invalid quality control testing or false positive patient results. |
| 2009-09-18 | Becton Dickinson & Co. | Product was shipped beyond its expiration date. |
| 2004-07-07 | Roche Molecular Systems Inc | An increased frequency of 'blue foci' that potentially can cause elevated A450 background in microwell plate wells after the addition of conjugate reagent during PCR detection. |
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